(161 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on LED light therapy with a simple automatic shut-off.
Yes
The device is intended to treat specific medical conditions, such as pain, arthritis, muscle spasm, and acne, by delivering light in the IR and blue spectrum, which aligns with the definition of a therapeutic device.
No
The device is intended to deliver heat via IR light for pain relief and improved circulation, and blue light to reduce the appearance of acne. These are therapeutic, not diagnostic, uses.
No
The device description explicitly states it is a "lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs)" and has a "console of the device contains the electronics of the device". This indicates it is a hardware device that emits light, not a software-only device.
Based on the provided information, the Biophotas LifeLight device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as delivering light (IR and blue spectrum) for therapeutic purposes on the body (topical heating, pain relief, acne reduction). IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health status.
- Device Description: The description focuses on the light-emitting technology and its application to the skin. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information about a disease or condition based on sample analysis.
- Using reagents or assays.
The Biophotas LifeLight device falls under the category of a therapeutic device that uses light energy for treatment.
N/A
Intended Use / Indications for Use
The Biophotas LifeLight™ 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.
Product codes
ILY, GEX
Device Description
The LifeLight® is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. LifeLight produces light in the near infrared region of the spectrum (880 nm) intended to provide topical heating to tissue. Blue light (464 nm) is intended to help reduce the appearance of mild to moderate acne.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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)
Device testing to demonstrate the ability of the infrared LED array to elevate topical tissue temperature confirmed that the LifeLight elevated skin to a temperature of between 40 – 45 C measured over the course of ten minutes of treatment, during which mid-treatment readings the device was deactivated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
Image /page/0/Picture/0 description: The image shows the word "biophotas" with a stylized graphic to the left of the word. The graphic is a series of dots arranged in a radiating pattern. The word "bio" is solid black, while the word "photas" is outlined in black.
JAN 0 3 2013
1122287
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 & prep date
The 510(k) owner is Biophotas, Inc., 250 El Camino Real, #114, Tustin, CA 92780
Phone: (714) 838 - 1956
Fax :
The contact person is Mr. Shepard G. Bentley, RAC
510(k) preparation date: 20 July, 2012
Name of the device, trade name, proprietary name, and classification name
Trade name: Biophotas LifeLight®
Common name: Infrared Lamp
Classification name: Lamp Infrared, Therapeutic Heating (ILY)
Predicate Device:
The legally marketed predicate for the Biophotas LifeLight® is:
K060792, illumiMed LED Phototherapy device
Device Description:
The LifeLight® is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. LifeLight produces light in the near infrared region of the spectrum (880 nm) intended to provide topical heating to tissue. Blue light (464 nm) is intended to help reduce the appearance of mild to moderate acne.
Indication for Use/Intended Use:
The Biophotas LifeLight™ 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.
The Intended Use information from the predicate product is equivalent and is reproduced below:
1
Image /page/1/Picture/0 description: The image shows the word "biophotas" in a stylized font. To the left of the word is a design made up of many small circles. The circles are arranged in a pattern that resembles a starburst or a network of connections. The word "biophotas" is written in lowercase letters, and the letters are a dark gray color.
K060792 illumiMed LED Phototherapy device
The illumiMed™ 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 acne vulgaris. Use of the combination of blue, red and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate inflammatory acne vulgaris.
Technological characteristics:
The Biophotas LifeLight® is a lightweight, portable light-emitting diode (LED) device which emits light energy. A blue LED array in the 464 nm spectrum is used in treatment for mild to moderate inflammatory acne. The near infrared LED array provides mild topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle pain. The console of the device contains the electronics of the device and an automatic shut-off safety feature. The LifeLight operates for 30 minutes per use. The LifeLight shares substantially equivalent wavelengths to its predicate devices for the related indications, and substantially equivalent energy source, energy delivery, target populations and locations for use.
| echnica
| racteristic | ||
|---|---|---|
| Wavelength | 464nm, 640nm, 880nm | 430nm, 660nm, 940nm |
| Electrical | ||
| power | 110 - 120 volts | 110 - 120 volts |
| Treatment | Twice weekly, 30 minutes per treatment | Every three days, 9 minutes per treatment |
| Energy | ||
| Delivery | ||
| (standard dose) | 465 nm - 19.6 Joules/cm2 | 430 nm - 18.9 Joules/cm2+ |
| Energy Output | 465 nm - 10.9 mW/cm2 | 430 nm - 35 mW/cm2 |
| Indicated Use | Acne, Pain | Acne, Pain |
| Use | Prescription | Prescription |
- = information taken from company user's manual †= information from predicate performance calculation
2
Image /page/2/Picture/0 description: The image shows the word "biophotas" with a stylized graphic to the left. The graphic is made up of many small circles arranged in a radial pattern. The word "biophotas" is written in a sans-serif font, with each letter outlined in black.
Nonclinical and clinical test data:
The Biophotas LifeLight® and the predicate devices have satisfied product safety testing to the IEC 60601-1 standard, and the electromagnetic safety testing to the IEC 60601-1-2 standard. Device testing to demonstrate the ability of the infrared LED array to elevate topical tissue temperature confirmed that the LifeLight elevated skin to a temperature of between 40 – 45 C measured over the course of ten minutes of treatment, during which mid-treatment readings the device was deactivated.
In summary, the BioPhotas LifeLight product is substantially equivalent to the predicate, utilizes mature technology and materials and provides a safe and effective addition to the substantial number of products cleared for these indications.
End of 510{k) Summary Section
Substantial Equivalence
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing the federal government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biophotas, Incorporated % Bentley Biomedical Consulting, LLC Mr. Shepard G. Bentley, RAC Director, Regulatory Affairs 250 El Camino Real #110 Tustin, California 92780
Re: K12237
Trade/Device Name: Biophotas LifeLight® Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY, GEX Dated: December 14, 2012 Received: December 17, 2012
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.
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 3, 2013
4
Page 2 - Mr. Shepard G. Bentley, RAC
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122237
Device Name: Biophotas Lifelight
Indications For Use: The Biophotas LifeLight 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 light is intended to reduce the appearance of mild to moderate acne vulgaris.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil R Ogden 2013.01.02 16:11:27 -05'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number K122237
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