Rule2026-08497
Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions
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Published
May 1, 2026
Effective
May 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the phototherapy device for reducing the appearance of acute post-surgical incisions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the phototherapy device for reducing the appearance of acute post-surgical incisions. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 91 Issue 84 (Friday, May 1, 2026)</title>
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[Federal Register Volume 91, Number 84 (Friday, May 1, 2026)]
[Rules and Regulations]
[Pages 23357-23359]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08497]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2026-N-4273]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Phototherapy Device for Reducing the Appearance
of Acute Post-Surgical Incisions
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
phototherapy device for reducing the appearance of acute post-surgical
incisions into class II (special controls). The special controls that
apply to the device type are identified in this order and will be part
of the codified language for classification of the phototherapy device
for reducing the appearance of acute post-surgical incisions. We are
taking this action because we have determined that classifying the
device into class II will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices, in part by reducing
regulatory burdens.
DATES: This order is effective May 1, 2026. The classification was
applicable on December 3, 2021.
FOR FURTHER INFORMATION CONTACT: Yan Fu, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-6278,
<a href="/cdn-cgi/l/email-protection#025b636c2c4477426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="336a525d1d7546735557521d5b5b401d545c45">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the
phototherapy device for reducing the appearance of acute post-surgical
incisions into class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness of the
device. In addition, we believe this action will enhance patients'
access to beneficial innovation, in part by reducing regulatory burdens
by placing the device into a lower device class than the automatic
class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified into, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug
[[Page 23358]]
Administration Modernization Act of 1997 (Pub. L. 105-115) established
the first procedure for De Novo classification. Section 607 of the Food
and Drug Administration Safety and Innovation Act (Pub. L. 112-144)
modified the De Novo classification process by adding a second
procedure. A device sponsor may utilize either procedure for De Novo
classification.
Under the first procedure, the person submits a premarket
notification (510(k)) for a device that has not previously been
classified. After receiving an order from FDA classifying the device
into class III under section 513(f)(1) of the FD&C Act, the person then
requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). As a result, other device sponsors do not have to submit a
De Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On February 4, 2020, FDA received Klox Technologies Inc.'s request
for De Novo classification of the Klox Biophotonic LumiHeal System. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness of the device, but there is sufficient information to
establish special controls that, in combination with the general
controls, provide reasonable assurance of the safety and effectiveness
of the device for its intended use (see section 513(a)(1)(B) of the
FD&C Act). After review of the information submitted in the request, we
determined that the device can be classified into class II with the
establishment of special controls. FDA has determined that these
special controls, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, on December 3, 2021, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
878.4880.\1\ We have named the generic type of device ``phototherapy
device for reducing the appearance of acute post-surgical incisions,''
and it is identified as consisting of a light-emitting device and a
photoconverter gel and is intended to employ light energy for reducing
the appearance of acute post-surgical incisions. This classification
does not include products which contain drugs or biologics.
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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FDA has identified the risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
Table 1--Risks to Health and Mitigation Measures for Phototherapy Device
for Reducing the Appearance of Acute Post-Surgical Incisions
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Identified risks to health Mitigation measures
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Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Sterility testing; Shelf-life
testing; and Labeling.
Thermal damage and ocular injury....... Non-clinical performance
testing; Thermal safety
testing; and Labeling.
Shock or burns from electrical Electrical safety testing;
malfunction or electromagnetic Electromagnetic compatibility
interference with other devices. testing; and Software
verification, validation, and
hazard analysis.
Use error that may result in injury.... Labeling; and Software
verification, validation, and
hazard analysis.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness of the device. For a device to
fall within this classification, and thus avoid automatic
classification in class III, it would have to comply with the special
controls named in this final order. The necessary special controls
appear in the regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for phototherapy devices for
reducing the appearance of acute post-surgical incisions. This device
is therefore subject to premarket notification requirements under
section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not normally have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget
[[Page 23359]]
(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The collections of information in part 860, subpart D, regarding De
Novo classification have been approved under OMB control number 0910-
0844; the collections of information in 21 CFR part 814, subparts A
through E, regarding premarket approval have been approved under OMB
control number 0910-0231; the collections of information in part 807,
subpart E, regarding premarket notification submissions have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820 regarding quality management system
regulation have been approved under OMB control number 0910-0073; and
the collections of information in 21 CFR part 801 regarding labeling
have been approved under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for part 878 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 878.4880 to subpart E to read as follows:
Sec. 878.4880 Phototherapy device for reducing the appearance of
acute post-surgical incisions.
(a) Identification. This device consists of a light-emitting device
and a photoconverter gel and is intended to employ light energy for
reducing the appearance of acute post-surgical incisions. This
classification does not include products which contain drugs or
biologics.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use.
Testing must include the following:
(i) Verification and validation testing of the spectrum and power
intensity of the light source;
(ii) Heat dissipation from the area following device application;
and
(iii) Biophotonic properties of the photoconverter gel, including
radiant fluence (transmitted light and fluorescence) delivered through
the photoconverter gel by the device.
(2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance data must evaluate the sterility of the patient-
contacting components of the device.
(4) Performance data must support the shelf life of the
photoconverter gel by demonstrating continued sterility and functional
performance over the identified shelf life.
(5) Performance testing must demonstrate the electromagnetic
compatibility, electrical safety, and thermal safety of the device in
the intended use environment.
(6) Software verification, validation, and hazard analysis must be
performed for any software components.
(7) Labeling must include the following:
(i) A summary of the device technical specifications, including
light wavelength, irradiance, and application area;
(ii) Warnings for ensuring eye safety, including use of protective
eyeglasses used for both the operator and the patient; and
(iii) A shelf life for the photoconverter gel.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08497 Filed 4-30-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 1, 2026.
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