BIOPHOTAS CELLUMA
Device Facts
| Record ID | K131113 |
|---|---|
| Device Name | BIOPHOTAS CELLUMA |
| Applicant | Biophotas, Inc. |
| Product Code | ILY · Physical Medicine |
| Decision Date | Jan 15, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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.
Device Story
Portable, AC-powered therapeutic device; utilizes super-luminous LEDs to emit polychromatic energy. Flexible panel contains red (640 nm), near-infrared (880 nm), and blue (463 nm) LEDs. Device conforms to body contours (back, face, knees). Operates via user interface console. Provides topical heating for pain relief, stiffness reduction, and increased local blood circulation; blue light reduces mild-to-moderate inflammatory acne. Used in home and clinical settings (spas, medical offices) by patients or professionals. Biocompatible Poron material used on patient-contact surfaces. Software-operated; design includes human factors/comprehension self-selection study to mitigate misuse risks.
Clinical Evidence
Bench testing only. Device validated for electrical/mechanical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993). Software validated per FDA requirements. Human factors/comprehension self-selection study performed to ensure safe OTC use and mitigate risks of misuse.
Technological Characteristics
Portable, AC-powered device. Flexible panel with super-luminous LED array (640 nm red, 880 nm near-IR, 463 nm blue). Patient-contact surface: biocompatible Poron material. Flame-retardant plastic console. Software-controlled. Safety standards: IEC 60601-1 (electrical/mechanical), IEC 60601-1-2 (EMC), ISO 10993 (biocompatibility).
Indications for Use
Indicated for individuals suffering from minor muscle/joint pain, arthritis, muscle spasms, stiffness, and mild to moderate inflammatory acne vulgaris. Intended for both home use and professional clinical settings (dermatologists, chiropractors, physical therapists, estheticians).
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- BioPhotas LifeLight® (K122237)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the word "biophotas" in a stylized font, with a logo to the left. The logo is a cluster of dots arranged in a radial pattern, resembling a star or a flower. The word "biophotas" is written in a sans-serif font, with each letter outlined in a thin black line. The overall design is simple and modern, with a focus on clean lines and geometric shapes.
K131113 Page 1 of 3
JAN 1 5 2014
## Traditional 510(k) Summary
As required in 21CFR807.92, we hereby submit this 510(k) Summary:
## 510(k) owner's name, address, phone, fax, contact person and prep date
The 510(k) owner is BioPhotas, Inc., 250 El Camino Real, #110, Tustin, CA 92780
Phone: (714) 838 - 1956
Fax: (949) 606 - 8191
The contact person is Mr. Shepard G. Bentley, RAC
510(k) preparation date: 18 March, 2013
## Name of the device, trade name, proprietary name, and classification name
Trade Name and Proprietary Name: BioPhotas Celluma®
Common Name: Infrared Lamp
Classification Name: Lamp Infrared, Therapeutic Heating (ILY)
### Predicate Device:
The legally marketed predicate for the BioPhotas Celluma® is:
### K122237, BioPhotas LifeLight®
#### Device Description:
The BioPhotas Celluma® is a therapeutic device using wavelengths of polychromatic energy produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and body conditions. It is a pain-free means to address a variety of musculoskeletal concerns. The Celluma® spectrum 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; promotion of relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue light spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat various conditions, specifically indicated to treat mild to moderate inflammatory acne vulgaris.
> 250 El Camino Real #110, Tustin, CA 92780 (714) 838 – 1956 / (714) 838 – 1447 fax
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Image /page/1/Picture/1 description: The image shows the word "biophotas" in a stylized font. To the left of the word is a graphic of a starburst pattern made up of many small dots. The letters in the word "biophotas" are black, but the letters "o", "p", "h", "o", "t", and "a" have a textured pattern inside of them.
Device Identification and Characteristics: The BioPhotas Celluma® is a portable, ACpowered, software operated device intended for use on areas of the body such as the back, face, knees or other areas where the therapeutic light may be beneficial. Drawing electrical energy through an AC power adaptor to a lightweight, flame-retardant plastic user interface console that connects by a cable to a flexible panel within which is mounted an array of LEDs which provide red light (640 nm) and near IR (880 nm) wavelengths necessary, the Celluma® provides topical heating to elevate tissue temperature for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain or muscle spasms and to provide a temporary increase in local blood circulation.
Blue LEDs, adjacent to the other LEDs, mounted within the flexible panel provide blue spectrum light (463 nm) intended to reduce mild to moderate inflammatory acne vulgaris.
The flexible panel is designed to conform to the contour of the treatment site providing for ease of use for sites that may be difficult to reach for larger, more cumbersome devices. The patient-facing surface of the panel may contact the tissue of the patient, and is therefore composed of biocompatible Poron material.
Environment of Use: End users of the device are expected to include the following:
- Home Use individuals suffering from various conditions as a result of aging, . disease and/or trauma
- . Medical professionals:
- o Dermatologists
- Primary Care Physicians o
- o Chiropractors
- Physicians Assistants o
- Medical Service Providers: .
- o Spa
- Nail Technicians and Estheticians o
- Massage Therapists 0
- Physical Therapists o
Usability of the Device: BioPhotas has performed a Usability Study to ensure the understanding of the proper use as well as any risks of misuse of the Celluma® by the public as an over-the-counter medical device product. The company undertook to study the selection for use of the device by a random population of prospective users to ensure adequate understanding of the proper uses of the device, specifically by means of a human factors/comprehension self-selection study. The study data show that the device design essentially mitigates anticipated risks of misuse and misunderstanding of the instructions for use.
> 250 El Camino Real #110, Tustin, CA 92780 (714) 838 – 1956 / (714) 838 – 1447 fax
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Image /page/2/Picture/0 description: The image shows the word "biophotas" in a stylized font. To the left of the word is a graphic of a starburst pattern made up of many small circles. The word "bio" is in a solid black font, while the word "photas" is in a hollow font with a black outline. The image is in black and white.
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Nonclinical Testing: The subject device has been tested for electrical and mechanical product safety to the IEC 60601-1 standard (200 Edition) and electromagnetic compatibility to the IEC 60601-1-2 standard, and passed the testing without any failure. Furthermore, the subject device has been tested for biocompatibility to the applicable parts of the ISO 10993 standard, and has passed the testing without any failure. Finally, the software that has been developed for the subject device has been fully validated per FDA requirements for software validation. These test results serve to confirm that the Celluma does not raise any new issues of safety or effectiveness.
End of 510(k) Summary
250 El Camino Real #110, Tustin, CA 92780 (714) 838 – 1956 / (714) 838 – 1447 fax
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biophotas Mr. Shepard G. Bentley, RAC Consultant 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, California 92677
Re: K131113
Trade/Device Name: BioPhotas Celluma® Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY, GEX Dated: December 14, 2013 Received: December 17, 2013
Dear Mr. Bentley:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
January 15, 2014
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Page 2 - Mr. Shepard G. Bentley, RAC
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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.
For
Sincerely yours, Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for biophotas. The logo consists of a stylized symbol on the left, resembling a burst of dots emanating from a central point. To the right of the symbol is the word "biophotas" in a sans-serif font. The "bio" portion of the word is in solid black, while the "photas" portion appears to be textured or patterned, giving it a different visual weight.
# Indications for Use
# INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K131113
Biophotas Celluma® Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ence of CDRH, Office of Device Evaluation (ODE) Neil R Oget 2014.01 094 2 -05'00'
(Division Sign-Off) for BSA
Division of Surgical Devices
510(k) Number_K131113
