The BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The BIOPHOTAS Celluma CONTOUR is intended to deliver heat in the near infra-red 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 BioPhotas Celluma CONTOUR is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

Device Description

The BioPhotas Celluma CONTOUR is a Light emitting diode (LED) system that applies 640nm light for the purpose of reducing the circumference of the hips, waist, and thighs for aesthetic benefit, 640nm and 880nm light for the purpose of temporarily elevating skin temperature and 640nm and 880nm light for the purpose of treating full face wrinkles.

The BioPhotas Celluma CONTOUR comprises of a flexible, 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 foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of allows the device to be placed in contact with the skin.

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 "Contour" "wrinkles" and "Aches and Pains", 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 FDA 510(k) summary for the Biophotas Celluma CONTOUR (K232977) does not contain comprehensive details on acceptance criteria and specific study results in a format that would typically be described for a diagnostic AI device. This document is a premarket notification for a Class II medical device (Low Level Laser System For Aesthetic Use), and the information presented focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics through large-scale clinical trials with defined acceptance criteria and statistical proofs.

However, based on the information provided, I can extract and infer some points regarding performance testing and acceptance, particularly concerning safety and usability for an Over-The-Counter (OTC) device.

Here's a breakdown of the available information structured to address your questions, with the understanding that this device is not an AI diagnostic tool and thus many of your questions related to AI-specific metrics (e.g., MRMC, standalone algorithm performance, training set ground truth) are not applicable or explicitly stated for this type of device submission.

Description of Acceptance Criteria and Studies

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are mainly focused on demonstrating compliance with safety standards, usability for OTC use, and equivalence of technological characteristics to predicates. Performance is assessed through compliance with these standards and comparison to predicates.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (as demonstrated)
Electrical Safety	IEC 60601-1: ed 3.1	Successfully passed testing.
EMC Testing	IEC 60601-1-2: ed 4	Successfully passed testing.
Software Validation	IEC 62304:2015	Successfully passed testing; Software safety classification: Class A; FDA level of concern: Minor.
Usability/Label Comprehension	IEC 62366:2015 (Medical devices Application of usability engineering to medical devices)	No new use errors, hazardous situations, or hazard-related use scenarios were discovered. Improvement of the user interface design related to safety deemed unnecessary. Device is successfully used by laypersons (inferred from equivalence with OTC predicate and label comprehension study).
Biocompatibility	(Not explicitly stated, but implies compliance with relevant standards)	Hardware is identical to previously cleared versions (K122237, K131113, K152280, K171323, K211038) in terms of material, manufacturing, tissue contact type, and duration. No change in biocompatibility.
Technological Equivalence	Equivalent properties to predicates (e.g., energy type, wavelengths, intensity, treatment protocol, control, electrical power)	Proposed device is within the bandwidth of predicate wavelengths, has equivalent output intensities, identical treatment times, and equivalent electrical power to predicates.

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

Usability/Label Comprehension Study:
- Sample Size: 24 test subjects.
- Data Provenance: Not explicitly stated, but typically these studies are conducted prospectively with recruited participants in a controlled environment. The country is not specified.
For other non-clinical performance tests (electrical safety, EMC, software validation, biocompatibility), these are typically engineering tests performed on the device itself or its components (e.g., materials for biocompatibility) rather than human subjects. Thus, the concept of "sample size" for a test set (like for a diagnostic device) doesn't directly apply in the same way.

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

This question is largely not applicable as this device is not an AI diagnostic tool that requires expert ground truth for performance evaluation in the context of disease detection or measurement.

For the usability study, "ground truth" refers to whether lay users can correctly understand and operate the device safely based on labeling. This is assessed through questions and observation, not expert consensus on medical images or patient outcomes. The experts involved would be human factors engineers or usability specialists who design and analyze the study. The document does not specify the number or qualifications of such experts.

4. Adjudication Method for the Test Set

This question is not applicable for the type of studies described in this submission (safety, EMC, software validation, usability). Adjudication implies resolving disagreements among experts for ground truth establishment, which is relevant for diagnostic performance studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a light-emitting diode (LED) system for aesthetic and pain relief uses. It does not involve AI for diagnostic interpretation or human reader assistance.

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

Not Applicable. This device does not feature a standalone diagnostic algorithm. The software mentioned is for controlling the device's operational modes and safety features, not for standalone diagnostic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For safety and performance characteristics (electrical, EMC, software): The "ground truth" is adherence to established international and national engineering standards (IEC 60601-1, IEC 60601-1-2, IEC 62304). Third-party testing labs or in-house engineering teams confirm compliance.
For usability/label comprehension: The "ground truth" is the correct understanding and safe operation of the device by lay users, as measured by their responses to questions and observed interactions, compared against the intended use and safety protocols.
For biocompatibility: The "ground truth" is the material's previously established biocompatibility or demonstration of compliance with relevant biocompatibility standards (e.g., ISO 10993 series), confirmed by testing (which was not repeated here due to material identity to cleared devices).

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML system that utilizes a training set for model development in the context of diagnostic performance. The software is noted as a Class A medical device software (lowest risk) and its validation focuses on life cycle processes and functional correctness, not machine learning training.

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

Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this device, this question does not apply.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2023

Patrick Johnson CEO 15501 Red Hill Ave., #200 Tustin, California 92780

Re: K232977

Trade/Device Name: Biophotas Celluma CONTOUR Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: OLI, OHS, ILY Dated: September 21, 2023 Received: September 21, 2023

Dear Patrick Johnson:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tanisha L. Tanisha L. Hithe -S 2023.11.21 Hithe -S 15:16:15 -05'00' Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232977

Device Name BIOPHOTAS Celluma CONTOUR

Indications for Use (Describe)

The BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/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 a combination of blue and green. Below the word "biophotas" is the text "K232977" in black.

510(k) Summary (K232977)

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

Submitter's Name:	BioPhotas, Inc.
Submitter's Contact:	Patrick Johnson
Submitter's Address:	15501 Red Hill Ave., #200, Tustin, CA 92780
Phone:	714-978-0080
Email:	patrick.johnson@biophotas.com

Device Classification Information :

Device Trade Name:	Biophotas Celluma CONTOUR
Device Common name:	Low Level Light System for Aesthetic Use
Regulation Number:	21 CFR 878.5400
	21 CFR 890.5500
	21 CFR 878.4810
Regulatory Class:	Class II
Product Code:	OLI, ILY, OHS
Classification Panel:	General & Plastic Surgery
Predicate device(s)	Contour Light CL-100 device (K202955)Biophotas Celluma 3 (K171323).

Date Prepared: November 14th, 2023.

Device Description

Biophotas Celluma (K131113).

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

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Image /page/5/Picture/0 description: The image shows the logo for biophotas, with the name in blue and green. Below the name is the code K232977 in black. The logo is simple and modern, with a focus on the company name and code.

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 "Contour" "wrinkles" and "Aches and Pains", 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.

Indication for Use statement

The BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

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

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Image /page/6/Picture/0 description: The image shows the logo for "biophotas" in teal and light green. The word "bio" is in teal, and the word "photas" is in light green. To the left of the word "bio" is a teal graphic that looks like a starburst. Below the word "biophotas" is the code "K232977" in black.

Technological characteristics:

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

Property	Proposed device.Biophotas Celluma CONTOUR	Contour Light CL-100	Biophotas Celluma 3	Biophotas Celluma	Significantdifference
DeviceManufacturer	Biophotas Inc	Contour Research, LLC	Biophotas Inc	Biophotas Inc	na
Device Trade Name	Biophotas Celluma CONTOUR	Contour Light CL-100	Biophotas Celluma³	Biophotas Celluma	na
510(K) Number	K232977	K202955	K171323	K131113	na
Device ProductCode -Classification name	OLI, ILY, OHS	OLI, ILY	OHS	ILY	Identical to bothpredicates
Regulation Number	21 CFR 878.540021 CFR 890.550021 CFR 878.4810	21 CFR 878.540021 CFR 890.5500	21 CFR 878.4810	21 CFR 890.5500	Identical
DeviceClassification	Class II	Class II	Class II	Class II	Identical
Rx/OTC	OTC	RX	OTC	OTC	Different
Intended use andIndications	The BIOPHOTAS Celluma CONTOUR isindicated for use as a non-invasivedermatological aesthetic treatment forthe reduction of circumference of hips,waist, and thighs.The BIOPHOTAS Celluma CONTOUR isintended to deliver heat in the nearinfra-red spectrum to provide topicalheating for the purpose of elevatingtissue temperature; for the temporary	The Contour Light CL-100 isindicated for use as a non-invasive dermatological aesthetictreatment forthe reduction of circumference ofhips, waist, and thighs.The Contour Light CL-100 isintended to deliver heat in the IRspectrum to provide topicalheating for the purpose ofelevating tissue temperature, forthe temporary relief of	The BioPhotas Celluma3 isintended to emit energy inthe visible and infraredregion of the spectrum foruse in the treatment offull-face wrinkles.	The BIOPHOTAS Celluma isintended to deliver heat inthe near infra-red spectrumto provide topical heatingfor the purpose of elevatingtissue temperature; for thetemporaryrelief of minor muscle andjoint pain, arthritis, andmuscle spasm; relievingstiffness; promoting therelaxation of muscle tissue;and to temporarily increaselocal blood circulation.	Identical
Property	Proposed device.Biophotas Celluma CONTOUR	Contour Light CL-100	Biophotas Celluma 3	Biophotas Celluma	Significantdifference
	relief of minor muscle and joint pain,arthritis, and muscle spasm; relievingstiffness; promoting the relaxation ofmuscle tissue; and to temporarilyincrease local blood circulation.The BioPhotas Celluma CONTOUR isintended to emit energy in the visibleand infrared region of the spectrum foruse in the treatment of full-facewrinkles.	minor muscle and joint pain,arthritis and muscle spasm;relieving stiffness; promoting therelaxation of muscle tissue; andto temporarily increase localblood circulation.
Non invasive	Yes	Yes	Yes	Yes	Identical
Energy Type	Light emitting diodes	Light emitting diodes	Light emitting diodes	Light emitting diodes	Identical
Peak Wavelength(FWHM)	Red: 640nm+/-25nm(615-665nm)880nm +/50nm(830nm - 930nm)	635nm880nm	Red: 640nm+/-25nmNIR: 880nm+/-50nm	Red: 640nm+/-25nmNIR: 880nm+/-50nm	Proposed device iswithin thebandwidth ofpredicates
Intensity(mW/cm2)	640nm - 4.2mW/cm2880nm - 0.7mW/cm2	635nm - 4.1mW/cm2880nm - 0.5mW/cm2	640nm - 4.2 mW/cm2880nm 0.7mW/cm2	640nm - 4.2 mW/cm2880nm 0.7mW/cm2	Equivalent
Treatment protocol(Treatment time)	30 minutes	30 minutes	30 minutes	30 minutes	Identical
Control	Device uses a timer and software tocontrol treatment duration.	Device uses a timer and softwareto control treatment duration.	Device uses a timer andsoftware to controltreatment duration	Device uses a timer andsoftware to controltreatment duration	Identical
Electrical power	90 – 264 VAC	85-264 VAC	90 – 264 VAC	90 - 264 VAC	Equivalent

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Similarities and Differences between the subject and predicate device:

Key Similarities

Please note: The proposed device Biophotas Celluma CONTOUR is technologically similar to the previously cleared Biophotas Celluma devices (K122237, K131113, K152280, K171323 and K211038). In this application, the software of the device has been modified to allow a red light only mode "Contour".

Indications for use

The proposed device, BioPhotas Celluma CONTOUR and Contour Light CL-100 device (K202955) use visible red light and are indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The proposed device and predicate are both intended to be used in the hip, waist, and thigh area.

Both devices are 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 proposed BioPhotas Celluma CONTOUR is identical to the Biophotas Celluma3 in that they are Over the Counter light emitting diode devices intended to emit energy in the visible and IR spectrums intended for the use in the treatment of full-face wrinkles.

The proposed BioPhotas Celluma CONTOUR is identical to the Biophotas Celluma (K131113) in that both devices are 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.

Light technology and wavelengths produced.

The predicate device Contour Light CL-100 (K202955) Celluma³ (K171323) Celluma (K131113) and Biophotas Celluma CONTOUR utilize Light emitting diodes as a light source and have equivalent wavebands of red light (615-665nm and 635nm) and 880nm (830nm - 930nm) and have equivalent output intensities.

Treatment parameters

BioPhotas Celluma CONTOUR and Contour Light CL-100 device (K202955) have identical treatment times and deliver equivalent doses of light over the 30 minutes treatment. BioPhotas Celluma CONTOUR in full face wrinkle mode is identical to Biophotas Cellumas (K171323) in terms of identical treatment times and equivalent doses of light over the 30 minutes treatment.

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BioPhotas Celluma CONTOUR in aches and pain mode is identical to Biophotas Celluma (K131113) in terms of identical treatment times and equivalent doses of light over the 30 minutes treatment.

Differences

The only difference between the Biophotas Celluma CONTOUR and predicate device Contour Light CL-100 K202955 is that the Biophotas CONTOUR is available "Over the counter" (OTC) whereas the Contour Light CL-100 K202955 is only available as prescriptive (Rx). This difference has been mitigated by Biophotas INC through the provision of a labeling comprehension study to demonstrate that the Biophotas CONTOUR can be used successfully by lay persons.

Electrical safety and safety standards

To demonstrate safety and effectiveness of the Biophotas Celluma CONTOUR and to demonstrate substantial equivalence to the predicate devices, Biophotas Inc has completed several non-clinical performance tests. Biophotas Celluma CONTOUR 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 Celluma CONTOUR successfully passed testing per internal verification/validation requirements and national/international standards illustrated below:

. Electrical safety per IEC 60601-1: ed 3.1
. EMC testing per IEC 60601-1-2: ed 4
. Software validation per IEC 62304:2015 and the FDA Guidance document.

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

Other Non-Clinical Performance testing

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

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

Biocompatibility

The hardware of the Biophotas Celluma CONTOURis identical to the previously cleared versions (K122237, K131113, K152280, K171323 and K211038) in terms of the material, manufacturing,

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tissue contact type and duration. There is no change in biocompatibility since the previously cleared versions.

Software verification and validation testing

In accordance with IEC 62304: 2015 Medical device Software - software life cycle process Biophotas Inc has allocated a software safety classification of Class A for the 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.

Labeling and label comprehension

The Biophotas Celluma CONTOUR has been assessed aqainst IEC 62366:2015 Medical devices Application of usability engineering to medical devices.

A usability comprehension study was conducted with 24 test subjects. Each test subject was provided with the product packaging and the User's Manual and device and allowed to read the labeling provided and interact with the product.

Following the subject's review of the User Manual, packaging, and the device the subject was asked a series of questions to address comprehension and understanding of the User Manual.

No new use errors, hazardous situations, or hazard-related use scenarios were discovered. Improvement of the user interface design as it relates to safety was deemed unnecessary.

Clinical performance testing

No Clinical performance data was included in the submission.

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 non-clinical performance testing 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. Therefore, the Biophotas CONTOUR as designed, and manufactured, has been demonstrated to be substantially equivalent to the referenced predicate Contour Light CL-100 K202955.

Biophotas has demonstrated that its CONTOUR device (K232977) as designed, and manufactured has the same intended use as the predicate devices, employs identical technological characteristics and is as safe, and as effective as the legally marketed predicates Contour Light CL-100 (K202955) and Biophotas Celluma 3 (K171323) and (K131113).

Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.