The Biophotas Celluma is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (blue, 465nm red, 640nm and Near infrared, 880nm) produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and musculoskeletal conditions. The Celluma' uses a combination of visible red light (640mm) in combination with near infrared light (880nm) and is intended to improve the appearance of full-face wrinkles. Near infra-red (880nm) is intended to provide topical heating tissue temperature: for the temporary relief of minor muscles and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum (465nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The Biophotas Celluma' is intended for use on areas of the body such as the full face, back, chest, knees or other areas where the therapeutic light may be beneficial. The system comprises of a semi-rigid, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible Poron® foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of Poron® allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device. The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes; "Acne", "Wrinkles", and "Aches and Pains", a pulse button which allows the user to switch between pulse (default setting) or non-Pulse and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.

AI/ML Overview

The provided text is a 510(k) summary for the Biophotas Celluma3, a device intended for the treatment of full face wrinkles. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with reported performance metrics.

Therefore, the following information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The sample size for the training set
How the ground truth for the training set was established

The document primarily relies on non-clinical performance testing and a comparison of technological characteristics to assert substantial equivalence. It explicitly states: "Biophotas Celluma' is technologically identical to the previously cleared Biophotas Cellumas device (K152280). In this application, only the indication for use has been revised to expand the treatment of periorbital wrinkles to include full face wrinkles, a logical extension given the fact that the subject device in both submission has a large panel covering the entire face. In addition, the mechanism of action of low level light therapy for the treatment of "wrinkles" is well known to be the same irrespective of area that is being treated."

The provided text details non-clinical performance testing to demonstrate safety and effectiveness for the Biophotas Celluma system, but this is distinct from a clinical study to prove efficacy in meeting acceptance criteria for wrinkle reduction.

Non-Clinical Performance Testing Summary:

The Biophotas Celluma3 underwent several non-clinical performance tests in line with recognized standards to demonstrate safety and effectiveness and substantial equivalence to predicate devices. These tests addressed general requirements, biocompatibility, electrical safety, and software.

Electrical safety and safety standards: The device passed testing per:
- IEC 60601-1:2012 (Electrical safety)
- IEC 60601-1-2:2007 (EMC testing)
Software verification and validation testing:
- The software was classified as Class A according to IEC 62304:2006 (Medical device Software - software life cycle process).
- The FDA level of concern matrix classified the device software as "Minor."
Biocompatibility: Based on transient and limited contact with intact skin, Biophotas Inc believes the device is safe and compliant with ISO 10993 and the FDA - Blue Book Memorandum #G95-1, supported by ISO 10993-1:2009 annex B.
Usability Study: Per IEC 62366.

The document argues that "Where there are slight differences in technological parameters, these fall within the range of the predicate devices and those devices cleared under the OHS device code, or have been negated by non-clinical performance testing." This indicates that the non-clinical tests were used to negate potential differences from predicate devices, rather than to establish new performance criteria for wrinkle reduction through a standalone clinical study.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a close-up of the address, and the text is clear and easy to read.

September 1, 2017

Biophotas Inc % Steven Baker Consultant ISMART Consulting US 1004 West Tuscany View Road #205 Midvale, Utah 84047

Re: K171323

Trade/Device Name: Biophotas Celluma3 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS Dated: May 3, 2017 Received: May 5, 2017

Dear Steven Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

{1}------------------------------------------------

with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171323

Device Name Biophotas Celluma3

Indications for Use (Describe)

The BioPhotas Celluma3 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for "biophotas". The logo consists of a blue, star-like symbol on the left, followed by the word "bio" in blue and "photas" in light green. The logo appears to be for a company or organization in the field of biophotonics or related areas.

Section 5: 510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).

Submitter's Name: BioPhotas, Inc. Submitter's Address: 1000 E. Howell Ave., Ste A, Anaheim, CA 92805 Phone: (714) 838-1956 Fax:

Date Prepared: April 30th 2017 Date amended: August 29th, 2017

Device Trade Name: Biophotas Celluma3

Device Common name:

Device Classification Information:

RegulationNumber	DeviceClassificationname	DeviceClass	Product Code	ClassificationPanel	Type
21 CFR878.4810	Powered light basednon-laser surgicalinstrumentLaser surgicalinstrument for use ingeneral and plasticsurgery and indermatology	Class 2	OHS - Lightbased OTC forwrinkle reduction.	General &Plastic Surgery	Traditional510 (k)

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for "biophotas". The logo consists of a stylized graphic to the left and the word "biophotas" to the right. The graphic is a blue burst of lines emanating from a central point. The word "biophotas" is written in a sans-serif font, with "bio" in blue and "photas" in green.

Device Description

The Celluma' uses a combination of visible red light (640mm) in combination with near infrared light (880nm) and is intended to improve the appearance of full-face wrinkles.

Near infra-red (880nm) is intended to provide topical heating tissue temperature: for the temporary relief of minor muscles and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The blue spectrum (465nm) is intended to reduce mild to moderate inflammatory acne vulgaris.

The Biophotas Celluma' is intended for use on areas of the body such as the full face, back, chest, knees or other areas where the therapeutic light may be beneficial.

The system comprises of a semi-rigid, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible Poron® foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of Poron® allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device.

The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes; "Acne", "Wrinkles", and "Aches and Pains", a pulse button which allows the user to switch between pulse (default setting) or non-Pulse and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.

Indications/Intended Use

The BioPhotas Celluma is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "biophotas" in a stylized font. The "bio" part of the word is in blue, while the "photas" part is in green. To the left of the word is a blue graphic that resembles a starburst or a cluster of connected dots.

Predicate devices

Pro X OTC 5 Light therapy device (K140471) Pulsaderm Wrinkle mask 28 (K163329) and Lightstim for Wrinkles (K120775)

The Pro X OTC 5 light therapy device, Pulsaderm Wrinkle mask 28, and Lightstim for wrinkles are all light therapy devices intended to emit energy in the visible and IR spectrums for the use in the treatment of full-face wrinkles.

All predicates devices are intended to treat the whole face.

Please note: The proposed device Biophotas Celluma3 is technologically identical to the previously cleared Biophotas Cellumad device (K152280). In this application, only the indication for use has been revised to expand the treatment of periorbital wrinkles to include full face wrinkles.

Technological characteristics:

The key technological characteristics of the subject device and predicate devices are summarized in the following table;

{6}------------------------------------------------

Property	Celluma 3	K140471 Pro X OTC5 Light Therapydevice	K163329Pulsaderm wrinklemask 28	K120775Lightstimfor wrinkles	Significantdifference
DeviceManufacturer	Biophotas Inc	La Lumiere LLC	Pulsaderm LLC	LED intellectualproperties LLC	NA
Device Trade Name	Celluma³	Pro X OTC 5 LightTherapy device	Pulsaderm wrinklemask 28	Lightstim for wrinkles	NA
510(K) Number		K140471	K163329	K120775	NA
Device ProductCode -Classification name	OHS - Light based OTCfor wrinkle reduction	OHS - Light based OTCfor wrinkle reduction	OHS - Light basedOTC for wrinklereduction	OHS - Light basedOTC for wrinklereduction	No significantdifference
DeviceClassification	Class II	Class II	Class II	Class II	No significantdifference
Intended use andIndications	The BioPhotas Cellumais intended to emitenergy in the visible andinfrared region of thespectrum for use in thetreatment of full facewrinkles.	The Pro X OTC 5 Lighttherapy device is intendedfor the use in thetreatment of facialwrinkles and for peoplewith FP skin types I, IIand III	The Pulsaderm wrinklemask 28 is intended forthe use in the treatmentof facial wrinkles andfor people with FP skintypes I, II and III	The Lightstim forwrinkles is an Overthe Counter handhelddevice intended toemit energy in thevisible and IRspectrums intendedfor the use in thetreatment of full-facewrinkles.	No significantdifference
Intended Locationof Use	Whole face	Whole face	Whole face	Whole face	No significantdifference
Treatment area	Active treatment area of15" x 8"	Approximately 8" x 11"	Approximately 8" x11"	Active treatment area4 sq inches	Difference intreatment area ¹.
Property	Celluma 3	K140471 Pro X OTC5 Light Therapydevice	K163329Pulsaderm wrinklemask 28	K120775Lightstimfor wrinkles	Significantdifference
Energy Type	Light emitting diodes	Light emitting diodes	Light emitting diodes	Light emitting diodes	No significantdifference
Peak Wavelength(FWHM)	Red: 640nm+/-25nmNIR: 880nm+/-50nm	Red: 620nm – 630nmNIR: 850nm	Red: 620nm - 630nmNIR: 850nm	Red: 605, 630nm,660nm.NIR: 855nm	No significantdifference wavebandsare equivalent to thepredicate devices
Intensity (mW/cm2)	$6.5 mW/cm^2$	$19.80 mW/cm^2$	$21.18 mW/cm^2$	$65 mW/cm^2$	Difference inintensity betweenCelluma3 andpredicates2
Treatment Dose(J/cm2)	$11.7 J/cm^2$	$17.8 J/cm^2$	$19 J/cm^2$	$11.7 J/cm^2$	Difference intreatment dose3
Treatment protocol(Treatment time)	3 treatments per week(1800 seconds)4 weeks	Daily, 15 minutes(900 seconds)	Daily, 15 minutes(900 seconds)	Daily per area(180 seconds)4 weeks	Cumulative treatmentprotocol is similar
Control	Device uses a timer andsoftware to controltreatment duration.	Device uses a timer andsoftware to controltreatment duration.	Device uses a timerand software to controltreatment duration	Device uses aON/OFF switch tocontrol treatmentduration	Difference in controlfunction. Negated byperformance testingto IEC 62304:2006
Electrical power	110-120V	Ni MH Batteries	Ni MH Batteries	110-120V	Difference in powersupply. Negated byelectrical safetytesting
Electrical Safety	60601-1:201260601-1-2:2007	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2	60601-1 part 160601-1-2 part 1-2	No significantdifference

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for biophotas. The logo consists of a blue, stylized image of a molecule on the left, followed by the word "bio" in blue and "photas" in green. The logo is simple and modern, and it is likely used to represent a company or organization that is involved in the field of biophotonics.

1,2,3,4 – See Differences pages 6-7

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for "biophotas". The logo consists of a blue, stylized image of radiating lines on the left, followed by the word "biophotas" in blue and green. The "bio" part of the word is in blue, while the "photas" part is in green.

Similarities and Differences between the subject and predicate device:

Key Similarities

Indications for use

The proposed device BioPhotas Celluma is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.

The predicate devices are all Over the Counter light emitting diode devices intended to emit energy in the visible and IR spectrums intended for the treatment of full-face wrinkles. All systems are intended to treat the whole face.

Wavelengths Produced

The predicate devices and the Biophotas Celluma2 all use light emitting diodes to produce energy and all emit in the visible red and near infra-red regions of the spectrum to treat full face wrinkles.

Differences

1. Difference in treatment area

Biophotas Celllumas and Pro X OTC 5 light Therapy device (K140471) and Pulsaderm wrinkle mask 28 (K163329) are similar in treatment area and are designed to cover the full face.

There is a difference between Biophotas Celllumas and Lightstim for Wrinkles (K120775). Lightstim for wrinkles has a treatment area of (4''2) the Biophotas Celluma3 has an active treatment area of 15' x 8'. The variance in treatment area does not create a significant difference since the user is required to move the Lightstim for wrinkles over the treatment area for the area (whole face) to receive the stated treatment dose.

In addition, it should be noted that the Lightstim for Wrinkles (K120775) has been successfully used as a predicate to clear panel devices. The LightStim Professional 2-Panel Light System(K150098) was cleared using (K120775) without additional clinical data.

2. Energy Output

Biophotas Cellluma" and Pro X OTC 5 Light Therapy device (K140471) and Pulsaderm wrinkle mask 28 (K163329) are similar in terms of output intensity and treatment dose. There is a difference between the output intensity of the Biophotas Cellumas and the Lightstim for wrinkles (K120775) however the total cumulative dose per treatment area is identical (11.7 J/cm-).

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image contains the word "biophotas" in a stylized font. The "bio" portion of the word is in a teal color, while the "photas" portion is in a light green color. To the left of the word is a teal-colored graphic that resembles a starburst or a cluster of interconnected points.

3. Control

There is no difference in the control function of the Biophotas Cellumas and Pro X OTC 5 light Therapy device (K140471) and Pulsaderm wrinkle mask 28 (K163329), all use a timer to control the duration of the treatment. The Lightstim for wrinkles (K120775) uses a simple on/off switch that the user operates to control the time of the treatment. The Biophotas Celluma" Biophotas Celluma software has been classified using the FDA level of concern matrix as Minor and the software contained within the Biophotas Celluma' has been tested to International standard 62304:2006 to ensure safety. Therefore, non-clinical performance testing negates any difference between the subject and predicate device K120775.

Non-clinical Performance testing

To demonstrate safety and effectiveness and substantial equivalence the Biophotas Celluma system has undergone several non-clinical performance tests in line with recognized standards in terms of general requirements, biocompatibility, electrical safety and software.

The following non-clinical performance data is provided in support of the substantial equivalence determination;

Electrical safety and safety standards

To demonstrate safety and effectiveness of the Biophotas Cellumad and to demonstrate substantial equivalence to the predicate devices, Biophotas has completed several non-clinical performance tests. The Celluma meets established requirements for overall design, electrical safety, software validation and usability studies confirming that the design outputs meet design input requirements and established specifications.

The Biophotas Cellumas successfully passed testing per internal verification/validation requirements and national/international standards illustrated below:

Electrical safety per IEC 60601-1 ●
EMC testing per IEC 60601-1-2 ●
Software validation per IEC 62304 and the FDA Guidance document ●
Usability Study per IEC 62366 ●

The Biophotas Cellumas and the predicate devices have satisfied product safety testing to the IEC 60601-1 standard, and the electromagnetic safety testing to the IEC 60601-1-2 standard.

Biocompatibility

Considering the intended use for the Biophotas Celluma3 LED system only transient and limited contact with intact skin takes place. Biophotas Inc believes that the device is safe and compliant with the requirements of ISO 10993 and the FDA - Blue Book Memorandum #G95-1in terms of biocompatibility. This position is supported by ISO 10993-1:2009 annex B.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for "biophotas". The logo consists of a stylized graphic to the left of the word "biophotas". The graphic is a blue burst of dots emanating from a central point. The word "biophotas" is written in a sans-serif font, with "bio" in blue and "photas" in light green.

Software verification and validation testing

In accordance with IEC 62304: 2006 Medical device Software - software life cycle process Biophotas Inc has allocated a software safety classification of Class A for the Biophotas Celluma LED system. The software has also been classified using the FDA level of concern matrix and the level of concern for the device software is: Minor.

Statement of Substantial Equivalence:

513(i) of the FD&C Act (21 U.S.C. 360c(i) states that for substantial equivalence a proposed device is required to have the same intended use and similar technological characteristics as the predicate device(s). Where there are differences in technological characteristics, these can be negated by appropriate clinical or scientific data demonstrating that the proposed device is as safe and effective as the predicate device, and that the proposed device does not raise any different questions of safety and effectiveness than the predicate device for the same intended use.

Biophotas Celluma' is technologically identical to the previously cleared Biophotas Cellumas device (K152280). In this application, only the indication for use has been revised to expand the treatment of periorbital wrinkles to include full face wrinkles, a logical extension given the fact that the subject device in both submission has a large panel covering the entire face. In addition, the mechanism of action of low level light therapy for the treatment of "wrinkles" is well known to be the same irrespective of area that is being treated.

Biophotas INC has demonstrated that the Biophotas Cellumas device has the same intended use as the predicate devices, and employs equivalent technology and similar technological parameters. Where there are slight differences in technological parameters, these fall within the range of the predicate devices and those devices cleared under the OHS device code, or have been negated by non-clinical performance testing.

Therefore, the Biophotas Celluma', as designed and manufactured, has been demonstrated to be substantially equivalent to the referenced predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.