(146 days)
Not Found
No
The device description focuses on the hardware components (LEDs, power supply, switch) and the mechanism of action (light emission). There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for the "treatment of periorbital wrinkles," which signifies a therapeutic purpose.
No
The device is intended for the treatment of periorbital wrinkles, indicating a therapeutic rather than a diagnostic purpose. It treats a condition, it does not identify or analyze one.
No
The device description explicitly details hardware components such as LEDs, a hand piece housing, a printed circuit board, a switch, a receiver jack, a power cord, and a power supply. This indicates it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Anti-Wrinkle Light is a handheld device that emits light directly onto the skin for the treatment of periorbital wrinkles. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the treatment of wrinkles, which is a therapeutic application, not a diagnostic one.
The device description and intended use clearly indicate that it is a therapeutic device that interacts directly with the body's surface, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The Anti-Wrinkle Light, model: AAL, is a handheld device intended for use in the treatment of periorbital wrinkles
The Anti-Wrinkle Light is a hand held device intended to emit energy in the visible and IR regions of the spectrum for use in entergy in the visible and IR regions of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
ONE
Device Description
The Anti-Wrinkle Light, Model AAL is a hand-held device 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 wrinkles and rhytides, under-the-eye and corner-of-the-eye regions
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)
A clinical study has been submitted. Individual subjects participating in the clinical study treated only under-the-eye and comer-of-the-eye regions, as shown in the current operator manual.
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.
K062991, K072459, K050216, K051255
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 K092800
Page ① of ③
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LED Intellectual Properties, LLC
Device: Anti-Wrinkle Light, Model AAL
- General Information
Date Prepared: September 8th, 2008
Submitter: AEGIS Regulatory, Inc. 1131 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 9832 Chesterfield Circle Santa Ana, Ca. 92705 Tel.: (714) 602-2412 Contact: Steve Marchese Email: stevem@lightstim.com
2. Names and Code
Device Proprietary Name: Anti-Wrinkle Light, Model AAL
Classification Name: Laser Instrument for General and Plastic Surgery
Classification Code: ONE, Class II
3. Predicate Devices
Omnilux New-U (K062991) Light BioScience Gentlewaves Consumer LED (K072459) Omnilux Revive & Plus Combo (K050216) Emergo Group LumiPhase-R (K051255)
4. Device Description
The Anti-Wrinkle Light, Model AAL is a hand-held device 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
1
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- Device Comparison Table (Also attached Excel)
1092800
| Device: | Anti-Wrinkle Light | Predicate
New-U
PhotoTherpeutic | Predicate
Revive&Plus Combo
Photo Therapeutics | Predicate
GentlewavesConsumr
LightBioScience | Predicate
LumiPasel
Emergo Group |
|------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------------------------|----------------------------------------------------|----------------------------------------|
| Company: | LED Intellecual | | | | |
| FDA K#: | K092800 | K072459 | K050216 | K072459 | K051255 |
| Indication
For Use: | Same
Intended for Over-The-Counter use for the reduction of periobital wrinkles and rhytides. | Same | Same | Same | Same |
| Power: | AC to DC
605,630, | AC to DC | 110 volt AC | AC to DC | 110 volt AC |
| Wavelength: | 660,855nm | 633,830nm | 633, 830nm | 590nm | 660nm |
| Target size: | 4sq in | 4sq in | Approx. 150sq in | 2-4sq in | Approx. 150sq in |
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 S same materials as employed on predicate devices.
7. Indications for Use / Intended Use
The Anti-Wrinkle Light, model: AAL, is a handheld device intended for use in the treatment of periorbital wrinkles
8. Performance Data
After an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, | ED Intellectual Properties, LLC believes that no significant differences exist between the predicate devices listed in Section 3, above. A clinical study has been submitted.
We request substantially equivalency.
9. Additional Information
2
092800 Page (3) of (5)
Individual subjects participating in the clinical study treated only under-the-eye and comer-of-the-eye regions, as shown in the current operator manual
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3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing a human figure with outstretched arms, in a flowing, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB - 4 2010
LED Intellectual Properties, LLC % AEGIS Regulatory, Inc. Mr. Robert T. Wagner 1131 Anthem View Lane Knoxville, Tennessee 37922
Re: K092800
Trade/Device Name: Anti-Wrinkle Light, Model AAL 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: ONE Dated: February 01, 2010
Received: February 02, 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.
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
4
Page 2 - Mr. Robert T. Wagner
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: KO92800
Device Name: LED Intellectual Properties, LLC – Anti-Wrinkle Light model: AAL
Indications For Use:
The Anti-Wrinkle Light is a hand held device intended to emit energy in the visible and IR regions of the spectrum for use in entergy in the
visible and IR regions of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Prescription Use × Over-The-Counter Use __________ AND/OR (Part 21 CFR 801 Subpart D) (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)
Page 1 of
"NRO" and "2/4/10" are handwritten signatures.
"Division Sign-Off" is printed text.
(Division Sign-Off) (Division Sign-Only)
Division of Surgical, Orthopedic, Division of Surgices Divisionative Devices
K0928CC
510(k) Number 2