BioPhotas Celluma3
Device Facts
| Record ID | K152280 |
|---|---|
| Device Name | BioPhotas Celluma3 |
| Applicant | Biophotas, Inc. |
| Product Code | ILY · Physical Medicine |
| Decision Date | Mar 2, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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 Story
Celluma3 is a shapeable, portable LED panel; conforms to anatomical contours; uses biocompatible materials. Emits blue (464nm) light for mild/moderate inflammatory acne; red (640nm) and infrared (880nm) light for periorbital wrinkle reduction and topical heating for pain relief. Used in esthetician clinics or home settings; operated by patient or provider. Device delivers light energy to target tissue; heat elevation increases local circulation. Healthcare providers/users assess wrinkle reduction via visual inspection or Fitzpatrick Classification. Benefits include non-invasive pain management and aesthetic improvement of periorbital wrinkles.
Clinical Evidence
Prospective clinical study; 50 subjects enrolled, 42 completed; ages 30-75. Treatment: 30-min sessions, 3x/week for 4 weeks; 12-week post-treatment follow-up. Primary endpoint: reduction in periorbital wrinkle severity per Fitzpatrick Classification. Results: 2/3 dermatologists agreed majority of subjects achieved >=1 point reduction in wrinkle severity 12 weeks post-treatment. No adverse events reported.
Technological Characteristics
Lightweight, portable LED panel. Wavelengths: 465nm (blue), 640nm (red), 880nm (infrared). Biocompatible materials. Electrical safety: IEC 60601-1; EMC: IEC 60601-1-2. Biocompatibility: ISO 10993-5, 10993-10. Software validation: IEC 62304.
Indications for Use
Indicated for patients aged 30-75 with periorbital wrinkles, or those seeking temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, or requiring increased local blood circulation, and those with mild to moderate inflammatory acne vulgaris.
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
Submission Summary (Full Text)
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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)
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.
| 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:
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.
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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:<br>Table 5A – Device Comparison Chart | | | | |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| | BioPhotas Celluma<br>K131113 | BioPhotas Celluma3<br>K number TBD | Aklarus Phototherapy<br>System<br>K083183 | Significant<br>Differences |
| Regulation | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | Identical |
| Regulation<br>Name | Infrared Lamp | Infrared Lamp | Infrared Lamp | Identical |
| Indicated<br>Use | Acne, Pain | Acne, Pain, Wrinkles | Acne, Pain, Wrinkles | Identical to Aklarus,<br>Identical to Celluma<br>except wrinkles<br>added. |
| Indications<br>For Use | The BioPhotas<br>Celluma is intended<br>to deliver heat in the<br>IR spectrum to<br>provide topical<br>heating for the<br>purpose of elevating<br>tissue temperature;<br>for the temporary<br>relief of minor<br>muscle and joint<br>pain, arthritis and<br>muscle spasm;<br>relieving stiffness;<br>promoting the<br>relaxation of muscle<br>tissue; and to<br>temporarily increase<br>local blood<br>circulation. The blue<br>spectrum light is<br>intended to reduce<br>mild to moderate<br>inflammatory acne<br>vulgaris. | The BioPhotas<br>Celluma3 is intended to<br>deliver heat in the IR<br>spectrum to provide<br>topical heating for the<br>purpose of elevating<br>tissue temperature; for<br>the temporary relief of<br>minor muscle and joint<br>pain, arthritis and<br>muscle spasm;<br>relieving stiffness;<br>promoting the<br>relaxation of muscle<br>tissue; and to<br>temporarily increase<br>local blood circulation.<br>The blue spectrum<br>light is intended to<br>reduce mild to<br>moderate<br>inflammatory acne<br>vulgaris. The Celluma3<br>is intended to emit<br>energy in the red and<br>infrared spectrum for<br>use in dermatology for<br>the treatment of<br>periorbital wrinkles. | The Aklarus Blue (420nm +/-<br>10nm), is generally indicated<br>to treat dermatological<br>conditions and specifically<br>indicated to treat moderate<br>inflammatory acne vulgaris.<br>The Aklarus combination of<br>Red (628nm+/-10nm) and<br>Blue(420nm +/-10nm) is<br>intended to emit in the red,<br>blue regions of the spectrum<br>for use in dermatology<br>treatment of mild to<br>moderate acne vulgaris.<br>The Aklarus Anti-Aging Red<br>(628nm +/-10nm) and Anti-<br>Aging Infrared (880nm +/-<br>10nm) combination is<br>intended to emit energy in<br>the red and infra-red region<br>of the spectrum for use in<br>dermatology for the<br>treatment of periorbital<br>wrinkles.<br>The Aklarus Infrared (880nm<br>+/-10nm) is intended to emit<br>energy in the IR spectrum to<br>provide topical heating for<br>the purpose of elevating<br>tissue temperature; for the<br>temporary relief of minor<br>muscle and joint pain,<br>arthritis and muscle spasm;<br>relieving stiffness; promoting<br>the relaxation of muscle<br>tissue; and to temporarily<br>increase local blood<br>circulation where applied. | Identical to Aklarus,<br>Identical to Celluma<br>except wrinkles<br>added. |
| | BioPhotas Celluma<br>K131113 | BioPhotas Celluma3<br>K number TBD | Aklarus Phototherapy<br>System<br>K083183 | Significant<br>Differences |
| Mechanism<br>of Action | Use of visible blue<br>light in treatment of<br>acne, red light for<br>elevating tissue<br>temperature. | Use of visible blue light<br>in treatment of acne,<br>red light for elevating<br>tissue temperature<br>and IR light in<br>improving appearance<br>of periorbital wrinkles. | Use of visible blue light in<br>treatment of acne, red light<br>for elevating tissue<br>temperature and IR light in<br>improving appearance of<br>periorbital wrinkles. | Identical to Aklarus,<br>Identical to Celluma<br>except wrinkles<br>added. |
| Wavelengths | 465nm, 640nm,<br>880nm | 465nm, 640nm, 880nm | 420nm, 633nm, 830nm | Equivalence of blue<br>light in the 400nm<br>range previously<br>established<br>(K122237). |
| Electrical<br>power | 110 – 120 V | 110 – 120 V | 110 – 120 V | Identical |
| Treatment | 3 times a week for<br>30 min.<br>4 weeks | 3 times a week for 30<br>min.<br>4 weeks | Twice Weekly for 30 min.<br>4 weeks | Identical |
| Electrical<br>Safety | ISO 60601-1 &<br>collateral standards | ISO 60601-1 &<br>collateral standards | ISO 60601-1 & collateral<br>standards | Identical |
| Use | ОТС | OTC | Prescription | Identical to the<br>Celluma predicate,<br>Aklarus is an older<br>device. |
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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
