(64 days)
Not Found
No Reference Device(s) were found.
No
The device description focuses on the physical components and light wavelengths, with no mention of AI or ML algorithms for analysis, control, or other functions. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as being "intended for use in the treatment of periorbital wrinkles," which clearly indicates a therapeutic purpose.
No
The device is described as being for "treatment of periorbital wrinkles" and for "direct exposure to the skin," indicating a therapeutic rather than diagnostic function. It does not mention any ability to measure, analyze, or detect conditions.
No
The device description explicitly lists hardware components such as LEDs, a hand piece housing, a printed circuit board, a switch, a receiver jack, and a power supply.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is applied directly to the skin for treatment.
- The intended use is for treating periorbital wrinkles. This is a therapeutic use, not a diagnostic one.
- The device description focuses on light emission and application to the skin. There is no mention of analyzing biological samples.
The description clearly indicates this is a therapeutic device that uses light energy for a cosmetic/medical purpose (treating wrinkles).
N/A
Intended Use / Indications for Use
The Light for Wrinkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
The Light for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of low intensity light emitting diodes (LED's) that emit Low and Sub-IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.
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
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)
Taking into consideration the statement in"5. Substantial Equivalency" above, after an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, LED Intellectual Properties, LLC believes that no significant differences exist between the Light for Wrinkles and the predicate device listed in Section 3, above.
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.
LED Intellectual Properties, LLC - Anti-Wrinkle Light, Model AAL
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 K101190
LED Intellectual Properties, LLC.
Device: Light for Wrinkles
[JUL - 1 2010
- General Information
Date Updated: June 7, 2010
Submitter: AEGIS Regulatory, Inc. 31 Anthem View Lane Knoxville, TN 37922 Tel.: (865) 982-5552 Fax: (865) 381-1808 Contact: Robert T. Wagner Email: bob@fdalistingconsultants.com
On Behalf of: LED Intellectual Properties, LLC 3189-C Red Hill Ave. Costa Mesa, Ca. 92626 Tel.: (949) 394-2427 Contact: Steve Marchese Email: stevem@lightstim.com
- Names and Code
Device Proprietary Name: Light for Wrinkles Class Name: Laser Instrument for General and Plastic Surgery Classification Code: OHS, Class II Indications: Light Based Over-The-Counter Wrinkle Reduction
- Predicate Devices
LED Intellectual Properties, LLC - Anti-Wrinkle Light, Model AAL
1
loll9o
page (2) of (3)
4. Device Description
The Light for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of low intensity light emitting diodes (LED's) that emit Low and Sub-IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.
5. Substantial Equivalency
The Light for Wrinkles has the exact same technological characteristics including design, materials, power output (65nM/cm2), the exact same wavelengths, delivery system and power transformer as the LED Intellectual Properties, LLC - Anti-Wrinkle Light, Model AAL predicate.
6. Biocompatibility
The sections of the device that come in contact with the user are the HIPS plastic handle and glass polymer LED's, which are non-sterile and are the same materials as employed on predicate devices.
7. Indications for Use / Intended Use
The Light for Wrinkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.
2
/oll90
page of
6. Performance Data
Taking into consideration the statement in"5. Substantial Equivalency" above, after an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, LED Intellectual Properties, LLC believes that no significant differences exist between the Light for Wrinkles and the predicate device listed in Section 3, above.
We request substantially equivalency and OTC variance.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with three curved lines representing the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 1 2010
LED Intellectual Properties, LLC % AEGIS Regulatory, Inc. Mr. Robert T. Wagner 31 Anthem View Lane Knoxville, Tennessee 37922
Re: K101190
Trade/Device Name: Light for Wrinkles Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: Class II Product Code: OHS Dated: June 07, 2010 Received: June 15, 2010
Dear Mr. Wagner:
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.
4
Page 2 - Mr. Robert T. Wagner
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 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/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.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K101190
Device Name: Light for Wrinkles
Indications For Use:
The Light for Winkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pete Vhmo
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K/0//90