(61 days)
No
The device description details a simple LED system with preprogrammed modes and basic control circuitry. There is no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is indicated for medical purposes such as temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, temporarily increasing local blood circulation, and treating full-face wrinkles.
No.
The device is intended for dermatological aesthetic treatment, temporary relief of pain and stiffness, relaxation of muscle tissue, increase of local blood circulation, and treatment of full-face wrinkles. It delivers heat and emits light for therapeutic purposes and does not mention any diagnostic capabilities.
No
The device description clearly outlines hardware components including LEDs, a flexible frame, a control panel with buttons, and cables, in addition to the software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The BIOPHOTAS Celluma CONTOUR is a light-emitting device that applies light to the surface of the body for therapeutic and aesthetic purposes (reducing circumference, relieving pain, treating wrinkles). It does not analyze samples taken from the body.
- Intended Use: The stated intended uses are all related to applying light externally to the body for various physical effects.
Therefore, the description clearly indicates a device used for external treatment, not for analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OLI, OHS, ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips, waist, thighs, full-face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No Clinical performance data was included in the submission.
Several non-clinical performance tests were completed:
- 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.
- Biocompatibility: hardware is identical to previously cleared versions (K122237, K131113, K152280, K171323 and K211038)
- Software verification and validation testing: software safety classification of Class A per IEC 62304: 2015 Medical device Software. Level of concern is Minor per FDA level of concern matrix.
- Labeling and label comprehension: A usability comprehension study was conducted with 24 test subjects. No new use errors, hazardous situations, or hazard-related use scenarios were discovered.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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"
1
(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).
2
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
3
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 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.
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
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.
Biophotas Celluma (K131113).
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
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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 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 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 | Significant
difference |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Device
Manufacturer | 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 Product
Code -
Classification name | OLI, ILY, OHS | OLI, ILY | OHS | ILY | Identical to both
predicates |
| Regulation Number | 21 CFR 878.5400
21 CFR 890.5500
21 CFR 878.4810 | 21 CFR 878.5400
21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 890.5500 | Identical |
| Device
Classification | Class II | Class II | Class II | Class II | Identical |
| Rx/OTC | OTC | RX | OTC | OTC | Different |
| Intended use and
Indications | 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 | The Contour Light CL-100 is
indicated for use as a non-
invasive dermatological aesthetic
treatment for
the reduction of circumference of
hips, waist, and thighs.
The Contour Light CL-100 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 | 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. | The BIOPHOTAS Celluma 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. | Identical |
| Property | Proposed device.
Biophotas Celluma CONTOUR | Contour Light CL-100 | Biophotas Celluma 3 | Biophotas Celluma | Significant
difference |
| | 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. | minor muscle and joint pain,
arthritis and muscle spasm;
relieving stiffness; promoting the
relaxation of muscle tissue; and
to temporarily increase local
blood 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) | 635nm
880nm | Red: 640nm+/-25nm
NIR: 880nm+/-50nm | Red: 640nm+/-25nm
NIR: 880nm+/-50nm | Proposed device is
within the
bandwidth of
predicates |
| Intensity
(mW/cm2) | 640nm - 4.2mW/cm2
880nm - 0.7mW/cm2 | 635nm - 4.1mW/cm2
880nm - 0.5mW/cm2 | 640nm - 4.2 mW/cm2
880nm 0.7mW/cm2 | 640nm - 4.2 mW/cm2
880nm 0.7mW/cm2 | Equivalent |
| Treatment protocol
(Treatment time) | 30 minutes | 30 minutes | 30 minutes | 30 minutes | Identical |
| Control | Device uses a timer and software to
control treatment duration. | Device uses a timer and software
to control treatment duration. | Device uses a timer and
software to control
treatment duration | Device uses a timer and
software to control
treatment duration | Identical |
| Electrical power | 90 – 264 VAC | 85-264 VAC | 90 – 264 VAC | 90 - 264 VAC | Equivalent |
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Image /page/7/Picture/0 description: The image contains the logo for "biophotas" in blue and green. Below the logo is the identifier "K232977" in bold black font. The logo consists of a stylized graphic to the left of the word "biophotas."
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Image /page/8/Picture/0 description: The image shows the logo for biophotas. The logo consists of a blue and green stylized text "biophotas" with a blue graphic to the left. Below the logo is the text "K232977" in a bold, black font.
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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Image /page/9/Picture/0 description: The image shows the logo for biophotas. The logo consists of a blue, stylized image of a plant or flower on the left, followed by the word "biophotas" in blue and green. Below the word "biophotas" is the text "K232977" in black.
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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Image /page/10/Picture/0 description: The image shows the logo for "biophotas" in blue and green lettering. Above the word "bio" is a blue graphic of a starburst. Below the logo is the text "K232077" in black lettering.
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).