(504 days)
Not Found
No
The device description and performance studies focus on LED technology and its comparison to a predicate device, with no mention of AI or ML.
Yes
The device is intended for "treatment of periorbital wrinkles and rhytides," which indicates a therapeutic purpose.
No
Explanation: The device is intended for the treatment of periorbital wrinkles and rhytides, not for diagnosis.
No
The device description explicitly lists hardware components such as an LED array, lens, handpiece, circuit boards, and power supply.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of periorbital wrinkles and rhytides." This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a hand-held LED lamp that applies light to the skin. This is a physical intervention, not a test performed on a biological sample.
- No mention of biological samples: There is no indication that this device interacts with or analyzes any biological samples (like blood, urine, tissue, etc.), which is a core characteristic of IVDs.
Therefore, the GentleWaves Consumer LED Photomodulation Device is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
The GentleWaves Consumer is a hand-held device consisting of a low intensity light emitting diode (LED) lamp placed in contact with the skin at a fixed distance determined by its lens cover. The device components include an LED array, a lens, a handpiece, three circuit boards, a power supply enclosure and power supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
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)
Performance testing of the GentleWaves Consumer demonstrates no significant difference in spectral content as compared to the cleared GentleWaves device (K031425). Thus, performance and safety testing obtained for the cleared GentleWaves is fully applicable to the GentleWaves Consumer. In addition, a user study was performed to confirm that lay users were able to use the GentleWaves Consumer in accordance with its instructions for use.
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.
Not Found
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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510(k) SUMMARY
Light BioSciences, LLC's
GentleWaves Consumer LED Photomodulation Device (K062991)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Light BioScience, LLC 933 First Colonial Road, Suite 204 Virginia Beach, Virginia 23454
(757) 425-6900 Phone: Facsimile: (757) 425-3127
[5]] 15 [2
Richard Krupnick Contact Person:
Date Prepared: September 29, 2006
Name of Device and Name/Address of Sponsor
GentleWaves Consumer LED Photomodulation Device
Light BioScience, LLC 933 First Colonial Road, Suite 204 Virginia Beach, Virginia 23454
Common or Usual Name
Lamp, nonheating
Classification Name
Surgical powered laser instrument
Predicate Devices
Light BioScience, LLC's GentleWaves LED Photomodulation System (K031425)
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Intended Use / Indications for Use
The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
Technological Characteristics
The GentleWaves Consumer is a hand-held device consisting of a low intensity light emitting diode (LED) lamp placed in contact with the skin at a fixed distance determined by its lens cover. The device components include an LED array, a lens, a handpiece, three circuit boards, a power supply enclosure and power supply.
Performance Data
Performance testing of the GentleWaves Consumer demonstrates no significant difference in spectral content as compared to the cleared GentleWaves device (K031425). Thus, performance and safety testing obtained for the cleared GentleWaves is fully applicable to the GentleWaves Consumer. In addition, a user study was performed to confirm that lay users were able to use the GentleWaves Consumer in accordance with its instructions for use.
Substantial Equivalence
The GentleWaves Consumer is as safe and effective as the GentleWaves LED Photomodulation System. The GentleWaves Consumer has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the GentleWaves Consumer and its predicate device raise no new issues of safety or effectiveness. In addition, the difference in indication as an OTC device does not affect the device's therapeutic effect. Thus, the GentleWave Consumer is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular fashion around the symbol. The logo is black and white.
AUG 18 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Light Bioscience, L.L.C. % Hogan & Hartson, L.L.P. Mr. Jonathan S. Kahan 555 Thirteenth Street Northwest Washington, District of Columbia 20004
Re: K062991
Trade/Device Name: Gentlewaves™ Consumer LED Photomodulation Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHS Dated: February 15, 2008 Received: February 15, 2008
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of June 26, 2008.
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 (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); good manufacturing practice requirements as set
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Page 2 - Mr. Jonathan S. Kahan
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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milker
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K062991
Device Name: GentleWaves Consumer LED Photomodulation Device
Indications for Use:
The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_X_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millerman
(Division Sign-Off) (Division Sign-on) Restorative,
Division of General, Restorative, Division of Cological Devices
510(k) Number K06294
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