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 dermatology for the treatment of periorbital wrinkles.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Anti-Wrinkle Light, Model AAL:

It's important to note that the provided 510(k) summary (K092800) for the Anti-Wrinkle Light, Model AAL, is extremely limited in the detail it provides about the clinical study conducted. Many of the requested details are not present in the document.

Acceptance Criteria and Reported Device Performance

The document states, "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 predicate devices listed in Section 3, above. A clinical study has been submitted."

This implies that the acceptance criterion was likely demonstrating substantial equivalence to predicate devices, particularly in performance for the reduction of periorbital wrinkles and rhytides. However, the specific quantitative acceptance criteria (e.g., a certain percentage reduction in wrinkles, or a specific score improvement) and the corresponding reported device performance (i.e., the numerical results from the clinical study) are NOT provided in this summary.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the given information as the specific performance metrics and outcomes are absent. The general "performance" stated is that it is believed to be "no significant differences" from predicates.

Study Details:

Here's what can be extracted and what is missing:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Implicitly, substantial equivalence to predicate devices for the reduction of periorbital wrinkles and rhytides. No specific quantitative criteria (e.g., target percentage reduction, statistical significance) are stated.
- Reported Device Performance: Not provided in the summary. The summary only states that "LED Intellectual Properties, LLC believes that no significant differences exist between the predicate devices," implying successful performance relative to the predicates, but no specific outcome data is presented.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document only mentions "Individual subjects participating in the clinical study."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable as the device is a therapeutic light device, not an AI diagnostic/interpretive tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a therapeutic light device, not an AI algorithm. Its performance is measured directly on the patient's skin condition.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for a device intended for wrinkle reduction would typically involve clinical assessment of wrinkle severity before and after treatment, possibly using standardized grading scales (e.g., Fitzpatrick Wrinkle Scale, photonumeric scales) or objective measurements (e.g., 3D imaging). However, the specific method used is not detailed in this summary. It would fall under "outcomes data" or expert assessment of outcomes.
The sample size for the training set:
- This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. It's a light therapy device. The clinical study mentioned would be considered the validation or performance study, typically for demonstrating safety and effectiveness on an independent cohort.
How the ground truth for the training set was established:
- Not applicable for a therapeutic light device.

Summary

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510(k) SUMMARY K092800

Page ① of ③

글

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

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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	PredicateNew-UPhotoTherpeutic	PredicateRevive&Plus ComboPhoto Therapeutics	PredicateGentlewavesConsumrLightBioScience	PredicateLumiPaselEmergo Group
Company:	LED Intellecual
FDA K#:	K092800	K072459	K050216	K072459	K051255
IndicationFor Use:	SameIntended for Over-The-Counter use for the reduction of periobital wrinkles and rhytides.	Same	Same	Same	Same
Power:	AC to DC605,630,	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

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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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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

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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

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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

Regulation Number and Section

§ 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.