The BioPhotas Celluma3 is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. The Celluma3 is intended to emit energy in the red and infrared spectrum for use in dermatology for the treatment of periorbital wrinkles.

Device Description

The Celluma3 is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light to manage aesthetic and musculoskeletal conditions. Celluma3 produces light in the near infrared region of the spectrum (880nm) intended to provide topical heating to tissue for pain relief. Blue light (464nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) in combination with infrared light is intended to improve the appearance of wrinkles. Note that the Cellumad and the Celluma predicate device are technologically identical; only the indications for use have been revised to add treatment of periorbital wrinkles.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BioPhotas Celluma3, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Success Threshold)	Reported Device Performance
At least a one-point or greater reduction of wrinkle severity on the Fitzpatrick	At least two out of three Clinical Investigators agreed that a majority of test subjects experienced a one-point or greater reduction of wrinkle severity on the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital) 12 weeks following the completion of treatment. Clinical study results confirmed at least a full point reduction.
Classification of Facial Wrinkling (Perioral and Periorbital) 12 weeks following	High positivity rates from test subjects (though specific numeric rates are not provided in this document).
the completion of treatment for a majority of test subjects.
Demonstrated efficacy and effectiveness.	Deemed efficacious and demonstrating effectiveness by the study.

Explanation of the Acceptance Criteria and Study Details:

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Initially, 50 test subjects were recruited across seven aesthetician locations.
- The final test subject count was 42, as one site and seven test subjects dropped out.
Data Provenance: The document does not explicitly state the country of origin. It indicates that test subjects visited "a study center" and "seven esthetician locations," implying a prospective clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Three Clinical Investigators.
Qualifications of Experts: Board Certified Dermatologists. One of them also served as the Principal Investigator.

4. Adjudication Method for the Test Set

Adjudication Method: It was an independent evaluation followed by a majority consensus. All three Clinical Investigators independently evaluated the test subjects' photos. The success criterion was met if "at least two out of three Clinical Investigators agreed that a majority of test subjects have experienced a one point or greater reduction." This is a form of 2-out-of-3 consensus adjudicated by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing AI with human readers or human readers with and without AI assistance was not done. This study focused on the device's efficacy for treating periorbital wrinkles, with expert assessment of before-and-after photos.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. The Device, Celluma3, is an LED light therapy device, not an AI algorithm. The study evaluated the device's effectiveness in humans, with human experts performing the evaluation.

7. The Type of Ground Truth Used

Ground Truth Type: Expert consensus based on professional visual evaluation of photographs, applying the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital).

8. The Sample Size for the Training Set

The document describes a clinical study to confirm device efficacy, not an AI algorithm training process. Therefore, there is no specific "training set" mentioned in the context of machine learning. The device itself (Celluma3) is a physical light therapy device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

As there is no AI algorithm training set mentioned, this question is not applicable. The device's efficacy was established through the prospective clinical study described above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design, symbolizing the department's focus on health and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2016

Biophotas, Inc % Mr. Robert Seiple QPM Consulting, LLC 3817 Seville Rd Denton, Texas 76205

Re: K152280

Trade/Device Name: Biophotas Celluma3 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY, OHS, OLP Dated: December 30, 2015 Received: January 27, 2016

Dear Mr. Seiple:

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 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 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.

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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 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 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 yours,

Jennifer R. Stevenson -A

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) K152280

Device Name BioPhotas Celluma3

Indications for Use (Describe)

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 stylized butterfly-like design on the left, made up of many small blue circles arranged in a radial pattern. To the right of the butterfly is the word "biophotas" in a sans-serif font. The "bio" part of the word is in a teal color, while the "photas" part is in a light green color.

510(k) Summary

Traditional 510(k) Summary

As required in 21CFR 807.92, we hereby submit this 510(k) Summary:

510(k) owners name, address, phone, fax, contact person:

The 510(k) owner is BioPhotas, Inc., 250 El Camino Real, #110, Tustin, CA 92780

Phone: (714) 838-1956 Fax:

The contact person: Mr. Patrick Johnson

Date Prepared: March 200 2016

Name of the device, trade name, proprietary name, and classification name:

Trade name: Celluma³

Common name: Infrared Lamp

Classification name: Lamp Infrared, Therapeutic Heating (ILY), Over-The-Counter Powered Light Based Laser For Acne (OLP) and Light Based Over-The Counter Wrinkle Reduction (OHS). Note that the product does not employ laser light, but these product codes has been used for these devices.

Predicate Devices:

The legally marketed predicates for the BioPhotas Celluma³ are:

K131113, BioPhotas Celluma
. K083183, Aklarus Phototherapy System, Hill Laboratories, Frazer, PA.

Device Description:

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Image /page/4/Picture/0 description: The image shows the logo for "biophotas". The logo consists of a blue, stylized image of a butterfly or starburst made up of small circles on the left. To the right of the image is the word "biophotas" in a sans-serif font. The "bio" part of the word is in blue, while the "photas" part is in green.

Indication for Use/Intended Use:

The BioPhotas Cellumad is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate inflammatory acne vulgaris. The Celluma3 is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Intended Use information from the predicate products is equivalent and is reproduced below:

K131113 BioPhotas Celluma

The BioPhotas Celluma device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate inflammatory acne vulgaris. Note that the Celluma' is technologically identical to the Celluma device, only the indication has been revised to include treatment for periorbital wrinkles.

K083183 – Aklarus Phototherapy System

The Aklarus Phototherapy system utilizes blue light (420 nm) and the combination of red (628 nm) and blue (420 nm) to treat dermatology conditions – specifically indicated to treat moderate inflammatory acne.

The Aklarus anti-aging Red (628nm and Anti-Aging Infrared (880nm) combination is intended for use in dermatology for the treatment of periorbital wrinkles.

The Aklarus Infrared (880 nm) is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm,; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Technological characteristics:

The BioPhotas Celluma³ is a lightweight, portable light-emitting diode (LED) device which emits light energy. A blue LED array (464 nm) is used in treatment for mild to moderate inflammatory acne. A red LED array (640 nm) and an infrared LED array (880 nm) are used in combination for reduction of periorbital wrinkles. The near infrared LED array also provides mild topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle pain.

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Image /page/5/Picture/0 description: The image shows the logo for biophotas. The logo consists of a blue abstract symbol on the left, followed by the word "bio" in blue and "photas" in green. The abstract symbol appears to be a cluster of blue dots arranged in a pattern.

Substantial Equivalence:

Substantial Equivalence:Table 5A – Device Comparison Chart
	BioPhotas CellumaK131113	BioPhotas Celluma3K number TBD	Aklarus PhototherapySystemK083183	SignificantDifferences
Regulation	21 CFR 890.5500	21 CFR 890.5500	21 CFR 890.5500	Identical
RegulationName	Infrared Lamp	Infrared Lamp	Infrared Lamp	Identical
IndicatedUse	Acne, Pain	Acne, Pain, Wrinkles	Acne, Pain, Wrinkles	Identical to Aklarus,Identical to Cellumaexcept wrinklesadded.
IndicationsFor Use	The BioPhotasCelluma is intendedto deliver heat in theIR spectrum toprovide topicalheating for thepurpose of elevatingtissue temperature;for the temporaryrelief of minormuscle and jointpain, arthritis andmuscle spasm;relieving stiffness;promoting therelaxation of muscletissue; and totemporarily increaselocal bloodcirculation. The bluespectrum light isintended to reducemild to moderateinflammatory acnevulgaris.	The BioPhotasCelluma3 is intended todeliver heat in the IRspectrum to providetopical heating for thepurpose of elevatingtissue temperature; forthe temporary relief ofminor muscle and jointpain, arthritis andmuscle spasm;relieving stiffness;promoting therelaxation of muscletissue; and totemporarily increaselocal blood circulation.The blue spectrumlight is intended toreduce mild tomoderateinflammatory acnevulgaris. The Celluma3is intended to emitenergy in the red andinfrared spectrum foruse in dermatology forthe treatment ofperiorbital wrinkles.	The Aklarus Blue (420nm +/-10nm), is generally indicatedto treat dermatologicalconditions and specificallyindicated to treat moderateinflammatory acne vulgaris.The Aklarus combination ofRed (628nm+/-10nm) andBlue(420nm +/-10nm) isintended to emit in the red,blue regions of the spectrumfor use in dermatologytreatment of mild tomoderate acne vulgaris.The Aklarus Anti-Aging Red(628nm +/-10nm) and Anti-Aging Infrared (880nm +/-10nm) combination isintended to emit energy inthe red and infra-red regionof the spectrum for use indermatology for thetreatment of periorbitalwrinkles.The Aklarus Infrared (880nm+/-10nm) is intended to emitenergy in the IR spectrum toprovide topical heating forthe purpose of elevatingtissue temperature; for thetemporary relief of minormuscle and joint pain,arthritis and muscle spasm;relieving stiffness; promotingthe relaxation of muscletissue; and to temporarilyincrease local bloodcirculation where applied.	Identical to Aklarus,Identical to Cellumaexcept wrinklesadded.
	BioPhotas CellumaK131113	BioPhotas Celluma3K number TBD	Aklarus PhototherapySystemK083183	SignificantDifferences
Mechanismof Action	Use of visible bluelight in treatment ofacne, red light forelevating tissuetemperature.	Use of visible blue lightin treatment of acne,red light for elevatingtissue temperatureand IR light inimproving appearanceof periorbital wrinkles.	Use of visible blue light intreatment of acne, red lightfor elevating tissuetemperature and IR light inimproving appearance ofperiorbital wrinkles.	Identical to Aklarus,Identical to Cellumaexcept wrinklesadded.
Wavelengths	465nm, 640nm,880nm	465nm, 640nm, 880nm	420nm, 633nm, 830nm	Equivalence of bluelight in the 400nmrange previouslyestablished(K122237).
Electricalpower	110 – 120 V	110 – 120 V	110 – 120 V	Identical
Treatment	3 times a week for30 min.4 weeks	3 times a week for 30min.4 weeks	Twice Weekly for 30 min.4 weeks	Identical
ElectricalSafety	ISO 60601-1 &collateral standards	ISO 60601-1 &collateral standards	ISO 60601-1 & collateralstandards	Identical
Use	ОТС	OTC	Prescription	Identical to theCelluma predicate,Aklarus is an olderdevice.

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Image /page/6/Picture/0 description: The image shows the logo for biophotas. The logo consists of a blue, stylized image of a butterfly or starburst made up of small circles on the left. To the right of the image is the word "biophotas" in a sans-serif font, with "bio" in blue and "photas" in green.

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Image /page/7/Picture/0 description: The image shows the logo for "biophotas". The logo consists of a stylized, teal-colored, abstract butterfly or starburst shape made up of many small circles on the left. To the right of the shape is the word "biophotas" in a sans-serif font, with "bio" in teal and "photas" in a light green color.

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Image /page/8/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 "biophotas" in blue and green. The "bio" part of the word is in blue, while the "photas" part is in green. The logo is simple and modern, and the colors are bright and eye-catching.

K152280 Nonclinical Performance Data:

To demonstrate safety and effectiveness of the BioPhotas Celluma³ and to demonstrate substantial equivalence to the predicate devices, BioPhotas has completed a number of non-clinical performance tests. The Celluma meets established requirements for overall design, biocompatibility, electrical safety and software validation confirming that the design outputs meet design input requirements and established specifications.

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

. Biocompatibility per 10993-1 (specifically 10993-5 & 10993-10)
Electrical safety per IEC 60601-1
EMC testing per IEC 60601-1-2
. Software validation per IEC 62304 and the FDA Guidance document

Clinical Performance Data:

A human clinical study was conducted to confirm device efficacy for the additional indication (treatment of periorbital wrinkles).

Test subjects visited a study center for thirty minute treatments, three times per week, for a period of four weeks, and a twelve week post-treatment follow up after the final treatment. Test subjects had photos taken at the start, at the end of the four week treatment, and at the final twelve week post-treatment follow up visit.

Upon completion of the clinical study, all photos were sent to the Clinical Investigators for determination of periorbital wrinkle reduction results, applying the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital).

One of the three Clinical Investigators (Board Certified Dermatologists), acted as the Principal Investigator and all three Clinical Investigators independently evaluated the test subjects' photos for inclusion and final results.

The eligible study population is comprised of test subjects within the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital) and ages between 30 to 75 years, who meet all inclusion criteria for enrollment. Fifty test subjects were recruited across seven esthetician locations, with seven or eight patients per study center. The final test subject count was forty-two with one site and seven test subjects dropping out of the study prior to completion. There were no adverse events observed or reported during the study.

The periorbital wrinkle levels were measured, and professional visual evaluation performed by the Clinical Investigators to evaluate the efficacy of the Celluma on the improvements in periorbital wrinkles.

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Image /page/9/Picture/0 description: The image shows the logo for biophotas. The logo consists of a stylized, abstract symbol on the left, resembling a cluster of dots arranged in a radiating pattern, colored in teal. To the right of the symbol is the word "biophotas" in a sans-serif font, with "bio" in teal and "photas" in a light green color. The overall design is clean and modern.

At least two out of three Clinical Investigators agreed that a majority of test subjects have experienced a one point or greater reduction of wrinkle severity on the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital) 12 weeks following the completion of treatment.

Clinical Study results confirmed at least a full point reduction in the appearance of periorbital wrinkles, along with high positivity rates from test subjects; therefore, has deemed the Celluma efficacious, and demonstrating effectiveness.

Statement of Substantial Equivalence:

As defined by FDA, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared device(s). Alternatively the device may have the same intended use and different technological characteristics that have been demonstrated to show that the these differences do not raise any new or additional questions regarding its safety and effectiveness relative to the predicate device.

BioPhotas has demonstrated that the Celluma device has the same intended use as the predicate device, employs very similar technological characteristics, which in addition to the human clinical study results, demonstrated that the device does not pose any additional questions regarding safety and efficacy relative to the predicate.

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

End of 510(k) Summary Section

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.