BIOPHOTAS CELLUMA3

K171323 · Biophotas, Inc. · OHS · Sep 1, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171323
• Device Name: BIOPHOTAS CELLUMA3
• Applicant: Biophotas, Inc.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Sep 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The Biophotas Celluma3 is a portable, therapeutic device utilizing super-luminous LEDs to emit polychromatic light (blue 465nm, red 640nm, near-infrared 880nm). The system features a semi-rigid, shape-taking frame with an LED array, allowing it to be contoured to various body areas, including the full face, back, chest, or knees. It is intended for OTC use. A control panel, connected via cable, allows users to select from three preprogrammed modes (Acne, Wrinkles, Aches and Pains) and toggle pulse settings. The device incorporates an automatic shut-off safety feature. By delivering specific wavelengths, the device aims to improve the appearance of wrinkles, provide topical heating for minor muscle/joint pain, arthritis, and muscle spasms, and reduce mild to moderate inflammatory acne vulgaris. The device is designed to maintain a small distance between the skin and the LED surface, which is covered by a biocompatible Poron foam and transparent polycarbonate.

Clinical Evidence

Bench testing only. No clinical data was provided. Safety and effectiveness were demonstrated through non-clinical performance testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software validation (IEC 62304), usability studies (IEC 62366), and biocompatibility (ISO 10993-1).

Technological Characteristics

Portable LED-based light therapy device. Materials: Biocompatible Poron foam, transparent polycarbonate. Wavelengths: 465nm (blue), 640nm (red), 880nm (NIR). Energy: 110-220V AC. Form factor: Semi-rigid, contourable frame (15" x 8"). Connectivity: Wired control panel. Software: Class A (IEC 62304), Minor level of concern. Sterilization: Not applicable (transient skin contact).

Indications for Use

Indicated for the treatment of full face wrinkles in patients.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• Biophotas Celluma (K152280)
• LightStim Professional 2-Panel Light System (K150098)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)

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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: [phone] Fax:

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

Device Trade Name: Biophotas Celluma3

Device Common name:

Device Classification Information:

| Regulation<br>Number | Device<br>Classification<br>name | Device<br>Class | Product Code | Classification<br>Panel | Type |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------|------------------------------|------------------------|
| 21 CFR<br>878.4810 | Powered light based<br>non-laser surgical<br>instrument<br>Laser surgical<br>instrument for use in<br>general and plastic<br>surgery and in<br>dermatology | Class 2 | OHS - Light<br>based OTC for<br>wrinkle reduction. | General &<br>Plastic Surgery | Traditional<br>510 (k) |

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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 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.

#### 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.

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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;

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| Property | Celluma 3 | K140471 Pro X OTC<br>5 Light Therapy<br>device | K163329<br>Pulsaderm wrinkle<br>mask 28 | K120775<br>Lightstim<br>for wrinkles | Significant<br>difference |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Device<br>Manufacturer | Biophotas Inc | La Lumiere LLC | Pulsaderm LLC | LED intellectual<br>properties LLC | NA |
| Device Trade Name | Celluma³ | Pro X OTC 5 Light<br>Therapy device | Pulsaderm wrinkle<br>mask 28 | Lightstim for wrinkles | NA |
| 510(K) Number | | K140471 | K163329 | K120775 | NA |
| Device Product<br>Code -<br>Classification name | OHS - Light based OTC<br>for wrinkle reduction | OHS - Light based OTC<br>for wrinkle reduction | OHS - Light based<br>OTC for wrinkle<br>reduction | OHS - Light based<br>OTC for wrinkle<br>reduction | No significant<br>difference |
| Device<br>Classification | Class II | Class II | Class II | Class II | No significant<br>difference |
| Intended use and<br>Indications | The BioPhotas Celluma<br>is intended to emit<br>energy in the visible and<br>infrared region of the<br>spectrum for use in the<br>treatment of full face<br>wrinkles. | The Pro X OTC 5 Light<br>therapy device is intended<br>for the use in the<br>treatment of facial<br>wrinkles and for people<br>with FP skin types I, II<br>and III | The Pulsaderm wrinkle<br>mask 28 is intended for<br>the use in the treatment<br>of facial wrinkles and<br>for people with FP skin<br>types I, II and III | The Lightstim for<br>wrinkles is an Over<br>the Counter handheld<br>device intended to<br>emit energy in the<br>visible and IR<br>spectrums intended<br>for the use in the<br>treatment of full-face<br>wrinkles. | No significant<br>difference |
| Intended Location<br>of Use | Whole face | Whole face | Whole face | Whole face | No significant<br>difference |
| Treatment area | Active treatment area of<br>15" x 8" | Approximately 8" x 11" | Approximately 8" x<br>11" | Active treatment area<br>4 sq inches | Difference in<br>treatment area ¹. |
| Property | Celluma 3 | K140471 Pro X OTC<br>5 Light Therapy<br>device | K163329<br>Pulsaderm wrinkle<br>mask 28 | K120775<br>Lightstim<br>for wrinkles | Significant<br>difference |
| Energy Type | Light emitting diodes | Light emitting diodes | Light emitting diodes | Light emitting diodes | No significant<br>difference |
| Peak Wavelength<br>(FWHM) | Red: 640nm+/-25nm<br>NIR: 880nm+/-50nm | Red: 620nm – 630nm<br>NIR: 850nm | Red: 620nm - 630nm<br>NIR: 850nm | Red: 605, 630nm,<br>660nm.<br>NIR: 855nm | No significant<br>difference wavebands<br>are equivalent to the<br>predicate devices |
| Intensity (mW/cm2) | $6.5 mW/cm^2$ | $19.80 mW/cm^2$ | $21.18 mW/cm^2$ | $65 mW/cm^2$ | Difference in<br>intensity between<br>Celluma3 and<br>predicates2 |
| Treatment Dose<br>(J/cm2) | $11.7 J/cm^2$ | $17.8 J/cm^2$ | $19 J/cm^2$ | $11.7 J/cm^2$ | Difference in<br>treatment dose3 |
| Treatment protocol<br>(Treatment time) | 3 treatments per week<br>(1800 seconds)<br>4 weeks | Daily, 15 minutes<br>(900 seconds) | Daily, 15 minutes<br>(900 seconds) | Daily per area<br>(180 seconds)<br>4 weeks | Cumulative treatment<br>protocol is similar |
| Control | Device uses a timer and<br>software to control<br>treatment duration. | Device uses a timer and<br>software to control<br>treatment duration. | Device uses a timer<br>and software to control<br>treatment duration | Device uses a<br>ON/OFF switch to<br>control treatment<br>duration | Difference in control<br>function. Negated by<br>performance testing<br>to IEC 62304:2006 |
| Electrical power | 110-120V | Ni MH Batteries | Ni MH Batteries | 110-120V | Difference in power<br>supply. Negated by<br>electrical safety<br>testing |
| Electrical Safety | 60601-1:2012<br>60601-1-2:2007 | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | 60601-1 part 1<br>60601-1-2 part 1-2 | No significant<br>difference |

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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

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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-).

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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.

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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.