The LightStim for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of light emitting diodes (LED's) that emit Low and Sub IR light for direct exposure to the skin. The components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelength, 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 a 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 a breakdown of the acceptance criteria and the study information for the LightStim for Wrinkles K120775, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes two main types of studies used for the LightStim for Wrinkles (K120775) to establish substantial equivalence to its predicate device (Light for Wrinkles K101190): a Usability Study and a Clinical Study. The acceptance criteria are implicitly tied to demonstrating similar performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Goal	Reported Device Performance (LightStim for Wrinkles K120775)
Usability Study	1. Attract intended users.	All four goals of the Study were met.
	2. Consumers could self-select device using packaging.	All four goals of the Study were met.
	3. Consumers knowledge of packaging/manual.	All four goals of the Study were met.
	4. Consumers demonstrate ability to operate/care for device correctly.	All four goals of the Study were met. Indicating similar consumer usability to the predicate device.
Clinical Study	Reduction in full-face wrinkles (measured by Fitzpatrick Wrinkle Scale - FWS).	- Baseline FWS: 5.73 - After 8 weeks: 4.54 - 3-month follow-up: 4.2 This shows an average reduction in full-face wrinkles. The study's premise was to deliver similar results in full-face wrinkle reduction as the predicate device did for periorbital wrinkles, implying the magnitude of reduction or the percentage of participants showing reduction (100% for the predicate) was the implicit criterion. The document states it produced "similar results."

2. Sample Size and Data Provenance

Test Set (Clinical Study): 40 participants
Data Provenance: The document does not explicitly state the country of origin. It indicates it was an 8-week Clinical Study and a 3-month follow-up, suggesting a prospective study design.

3. Number of Experts and Qualifications for Ground Truth

The clinical study utilized the Fitzpatrick Wrinkle Scale (FWS) to judge wrinkle severity. The specific number of experts or their qualifications for assessing the FWS scores are not mentioned in the provided text. It is implied that trained personnel would have applied this scale, but no details are given.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the Fitzpatrick Wrinkle Scale assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in the provided text. The study focused on the device's efficacy on participants rather than comparing human readers' performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone clinical study was performed to assess the device's effectiveness in reducing full-face wrinkles without human-in-the-loop assistance (beyond what's inherent in user-operated devices). The results (FWS reduction) demonstrate the algorithm's (or device's) standalone impact.

7. Type of Ground Truth Used

The ground truth used for the clinical study was based on the Fitzpatrick Wrinkle Scale (FWS) scores, which are a standardized assessment of wrinkle severity. This is a form of expert assessment or clinical measurement.

8. Sample Size for the Training Set

The provided text does not mention a "training set" in the context of an algorithm or AI. This device is a light-emitting device, not an AI/software device that would typically have a training set for an algorithm. The clinical study participants (40 individuals) serve as the test set for the device's performance.

9. How Ground Truth for the Training Set Was Established

As the device is not an AI/software device that uses a "training set" in the conventional sense, this question is not applicable based on the provided information. The 40 participants in the clinical study are the "test set" to prove the device's efficacy, and their wrinkle severity was assessed using the FWS scale.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness

LED Intellectual Properties, LLC.

Device: LightStim for Wrinkles K120775

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

General Information

Date: March 8, 2012

Submitter:

LED Intellectual Properties, LLC . 16552 Von Karman Avenue Irvine, Calif. 92606 Fax: (949) 502-4090 Tel: (949) 502-4088 Email: steve@lightstim.com cell: (949) 394-2427 Contact: Steve Marchese

Device name and code

Device Proprietary Name: LightStim 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 - Light for Wrinkles (K101190)

Device Description

{1}------------------------------------------------

5. Indications for Use

The LightStim for Wrinkles is an Over-The-Counter handheld device intended for the use in the treatment of full-face wrinkles.

Substantial Equivalency

(a) The "LightStim for Wrinkles" K120775 is a new name for the predicate device "Light for Wrinkles". Substantial Equivalency Comparison chart is attached separately.

(b) (1) A Usability Study (equivalent to the Study conducted under K101190) with the following four goals was conducted utilizing 50 participants: (1).to attract participants that represented the "intended users" of the device; (2) to determine if consumers could correctly self-select using the Packaging labeling only; (3) to test consumer knowledge of the Packaging labeling and Instruction Manual; (4) to have consumers demonstrate their ability to adhere to what they had read in the Instruction Manual and actually operate and care for the device correctly. All four goals of the Study were met. indicating that the LightStim for Wrinkles K120775 has similar consumer usability to the Light for Wrinkles K101190.

(b) (2) An 8-week Clinical Study (equivalent to the Clinical Study conducted under K101190) with 40 participants was conducted with the premise that the LightStim for Wrinkles K120775 will deliver similar results in full-face wrinkle reduction to the Light for Wrinkles K101190 that was clinically tested for periorbital wrinkle reduction. The Study utilized the Fitzpatrick Wrinkle Scale (FWS) to judge wrinkle severity on a 1 through 9 basis. The outcome of the K120775 Clinical Study was that the participant's average fullface wrinkles base line was 5.73 on the FWS and at the end of the 8-weeks of treatment the average score revealed a reduction in full-face wrinkles to 4.54 on the scale. Further reduction to 4.2 on the scale was found at the 3-month follow-up after cessation of treatment.

(b) (3) The conclusion drawn by LED Intellectual Properties LLC, based on the facts that the LightStim for Wrinkles K120775 produced similar results in the Usability Study and similar results in the Clinical Study to the Light for Wrinkles K101190 is that the LightStim for Wrinkles raises no new issues of safety and has proven efficacy in the treatment of full-face wrinkles.

{2}------------------------------------------------

	6(a) Substantial Equivalence Comparision
Characteristic	Light for Wrinkles K101190	LightStim for Wrinkles K120775
Intended Use	The Light for Wrinkles is anOver-The-Counter handhelddevice intended for the use intreatment of periorbitalwrinkles.	The Light for Wrinkles is anOver-The-Counter hand-helddevice intended for the use intreatment of full-face wrinkles.
Indications for Use	Periorbital Wrinkles	Full-Face Wrinkles
Target Population	Women and men withperiorbital wrinkles	Women and men with full-facewrinkles
Anatomical Sites	Periorbital Area	Entire Face
Where Used	Home	Home
Energy Used and/or Delivered	9-volt DC powertransformer/approx.65mW/cm2	9-volt DC powertransformer/approx.65mW/cm2

	Usability Study with LabelingComprehension and self-selection conducted, with bothexhibiting results ofeffectiveness and safety.	Usability Study with LabelingComprehension and self-selection conducted, with bothexhibiting results ofeffectiveness and safety
Human factorsDesign	Hand-held deviceClinical Study of 100% of the 44participants exibiting areduction in fine lines andwrinkles in the periorbital area.	Hand-held deviceClinical Study of 100% of the 40participants exibiting areduction in facial wrinkles inthe periorbital area.
Performance	Power is approximately65mW/cm2.	Power isapproximately 65mw/cm2.
Standards Met	IEC-60601-1-2, IEC-60601-1, ISO10993, ISO-13485	IEC-60601-1-2, IEC-60601-1, ISO10993, ISO-13485
Materials	glass polymer, plastic, metal	glass plymer, plastic, metalglass polymer, ABS Lustran 348plastic
Compatibility with the Environment and Other Devices	glass polymer and plasticIEC-60601-1-2	IEC-60601-1-2Power Supply delivering a safe9-volts DC to the hand-helddevice. IEC-60601-1-2, and IEC-
Electrical Safety		60601-1
Mechanical Safety		IEC-60601-1
Thermal Safety		IEC-62471
Radiation Safety		IEC-62471

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 4 2012

LED Intellectual Properties % Mr. Steve Marchese CEO 16552 Von Karman Avenue Irvine . California 92606

Re: K120775

Trade/Device Name: LightSlim for Wrinkles Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: Class II

Product Code: OHS Dated: May 11, 2012 Received: May 22, 2012

Dear Mr. Steve Marchese:

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. Marchese

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 (OS) 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/Resourcesfor You/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}------------------------------------------------

K120775, 1 of 1

Indications for Use Statement

510(k)Number(if known)	K120775
Device Name	LightStim for Wrinkles

__ and__

Indications for Use

The LightStim for Wrinkles is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801. 109) OR

. Over-The-Counter Use

Nil RPOgden for nkm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number K120775

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.