LightStim for Acne Mini, model: LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the LightStim for Acne Mini device, based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the LightStim for Acne Mini are primarily based on demonstrating substantial equivalence to existing predicate devices. This means the device needs to show similar performance characteristics, indications for use, and safety attributes as the predicates. The document doesn't explicitly state quantitative performance targets for effectiveness (e.g., "reduce acne by X%"), but rather focuses on aligning with the established parameters of comparable devices already on the market.

Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (based on predicate devices)	Reported LightStim for Acne Mini Performance
Intended Use	Mild to moderate acne. (Matches all predicates: Tanda Skincare, Quasar Blue Light Therapy System, Silk'n Blue)	Mild to moderate acne. (Stated in the Indications for Use / Intended Use section and the comparison table. This is a direct match, indicating criterion met.)
Indications for Use	Treatment of mild to moderate acne. (Explicit from predicates)	Treatment of mild to moderate acne. (Explicit in the Indications for Use / Intended Use section and comparison table. This is a direct match, indicating criterion met.)
Target Population	Women and men with mild to moderate acne. (Matches all predicates)	Women and men with mild to moderate acne. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Output in mW	50mW/cm² (Matches all predicates)	50mW/cm². (Stated in the comparison table. This is a direct match, indicating criterion met.)
Treatment Time	3 to 4 minutes per area (Matches Quasar and Silk'n Blue predicates, Tanda is 3 minutes twice daily)	3 to 4 minutes per area. (Stated in the comparison table and Device Description. This aligns with two of the three predicates, with Tanda being slightly different but within a similar range for single treatment duration. This is considered met for substantial equivalence.)
Treatment Area (cm²)	In line with similar hand-held devices (Predicates range from 7 to 27 cm²)	15.5 cm². (Stated in the comparison table. This falls within the range of the predicate devices. This is considered met for substantial equivalence.)
Wavelengths (nm)	415 nm (Matches all predicates)	415 nm. (Stated in the comparison table and Device Description. This is a direct match, indicating criterion met.)
Where Used	Home use (Matches all predicates)	Home. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Design	Hand-held device (Matches all predicates)	Hand-held device. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Materials	Rigid ABS or similar (Predicates use Rigid ABS or Stainless Steel)	Rigid ABS. (Stated in the comparison table. This matches two of the three predicate devices, indicating criterion met.)
Electromagnetic Compatibility	IEC 60601-1-2 compliant (Matches all predicates)	IEC 60601-1-2. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Basic Safety and Essential Performance	IEC 60601-1 compliant (Matches all predicates)	IEC 60601-1. (Stated in the comparison table. This is a direct match, indicating criterion met.)
Radiation Safety	Addressed by recognized standards (Predicates "Unknown," but the subject device identifies its standard, suggesting adherence to modern safety practices)	IEC 62471/IEC 62471-2. (Stated in the comparison table. While predicates are "Unknown," the subject device explicitly states compliance with a relevant standard, suggesting it meets safety expectations in this regard, and likely exceeds the "unknown" status of predicates by providing a specific standard.) This is considered met for substantial equivalence.
Usability/User Comprehension	Users adequately decide whether to use the device and comprehend risks, warnings, cautions, precautions, and proper use.	"results showed that the participants adequately decided whether or not to use the device for their level of acne, and showed that users comprehended risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual." (Stated in the Performance Data section. This directly confirms meeting the criterion for usability.)

Study Details for LightStim for Acne Mini:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 40 participants.
- Data Provenance: The document does not explicitly state the country of origin. It appears to be a prospective study, as participants used the device and their comprehension and decision-making were evaluated as part of the study.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The study described is a usability study, not a clinical efficacy study requiring expert assessment of medical outcomes. Therefore, there is no mention of experts establishing a "ground truth" for acne severity or improvement. The "ground truth" for this study was user comprehension and appropriate device selection, which was assessed through observation and potentially questionnaires.
Adjudication Method for the Test Set:
- Not applicable. The study was a usability study focused on user comprehension, not on medical diagnoses or outcomes requiring adjudication by multiple experts.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This study focuses on usability and safety, not on comparing diagnostic accuracy or clinical effectiveness with or without AI assistance. The device is not an AI-powered diagnostic tool.
Standalone Performance Study:
- Yes, a standalone usability study was conducted. The described "Performance Data" section details a study where 40 participants used the device and were assessed on their "adequacy" in deciding to use the device and their "comprehension" of the instruction manual. This evaluates the device's human-interaction performance without comparison to other devices in terms of usability effectiveness.
Type of Ground Truth Used:
- For the usability study, the "ground truth" was user comprehension and appropriate decision-making regarding device use, as evaluated through the study protocol. This is observational/feedback-based, not medical pathology or outcomes data.
Sample Size for the Training Set:
- Not applicable. This device is a light therapy device, not an algorithm or AI model that requires a training set.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.

Summary

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K131461

Page 1 of 3

JAN - 6 2014

510(k) Summary of Safety & Effectiveness

LED Intellectual Properties, LLC.

Device: LightStim for Acne Mini, Model: LS4AM

1. General Information

・・

Submitter: LED Intellectual Properties, LLC 16552 Von Karman Ave. Irvine. CA 92606

Contact Porson: Steve Marchese Office: (949) 502-4088 Mobile: (865) 394-2427

Date Person: October 10, 2012

2. Names and Code

Device Name: LightStim for Acne Mini, model: L.S4AM

Classification Name: Laser Instrument, Surgical Powered -General and Plastic Surgery -Class 11, OLP

Although this device is not a laser and is intended for OTC use, the manufacturer thinks this is the closet applicable classification name.

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Page 2 of 3

3. Predicate Devices

Quasar Blue Light Therapy System (K093963), Tanda Skincare (K080591), Silkn Blue (121435)

4. Device Description

5. Indications for Use / Intended Use

LightStim for Acne Mini, model: LS4AM is intended for Over-The-Counter use for the treatment of mild to moderate acne.

6. Performance Data

A usability study of this device was conducted with 40 participants. The participants ranged in age from 11 to 61. The results showed that the participants adequately decided whether or not to use the device for their level of acne, and showed that users comprehended risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual.

Taking into consideration the table for substantial equivalence after an analysis of safety, indications, intended uses, performance, features, technological properties and methods of operations, LED Intellectual Properties, LLC believes that LightStim for Acne Mini has shown substantial equivalence to the predicate devices. Quasar Blue Light System (K093964), Tanda Skincare (K080591), Silkn Blue (121436).

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Characteristic	Tanda SkincareK080591	Quasar Blue Light Therapy System493963	Silk'n Blue121435	LightStim for Acne Mini
Intended Use	Mild to moderate acne.	Mild to moderate acne.	Mild to moderate acne.	Mild to moderate acne.
Indications for Use	There is no differencebetween the subject andthe predicate device inregards to indications foruse.	There is no differencebetween the subject andthe predicate device inregards to indications foruse.	There is no differencebetween the subjectand the predicatedevice in regards toindications for use	LightStim for Acne Miniis intended for the useto treat mild tomoderate acne.
Target Population	Women and men with mildto moderate acne.	Women and men with mildto moderate acne.	Women and men withmild to moderate acne.	Women and men withmild to moderate acne.
Output in mW	50mW/cm2	50mW/cm2	50mW/cm2	50mW/cm2
Treatment Time	Treat breakout areas for 3minutes, twice daily	3 minutes per area	3 to 4 minutes per area	3 to 4 minutes per area
Treatment Area (cm2)	27	10	7	15.5
Wavelengths (nm)	415	415	415	415
Where Used	Home	Home	Home	Home
Design	Hand-held device	Hand-held device	Hand-held device	Hand-held device
Materials	Rigid ABS	Stainless Steel	Rigid ABS	Rigid ABS
ElectromagneticCompatibility	60601-1-2	60601-1-2	60601-1-2	IEC 60601-1-2
Basic safety andessential performance	IEC 60601-1	EC 60601-1	IEC 60601-1	EC 60601-1
Radiation	Unknown	Unknown	Unknown	IEC 62471/IEC 62471-2

The conclusion drawn by LED Intellectual Properties. LLC. based on the comparison table and testing described above, is that the LightStim for Acne Mini raises no new issues of safety and is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an abstract symbol that resembles a person embracing another person.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 6, 2014

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

Re: K131461

Trade/Device Name: LightStim for Acne Mini 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: OLP Dated: December 02, 2013 Received: December 03, 2013

Dear Mr. 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.

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Page 2 - Mr. Steve Marchese, CEO

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.

Binita S. Ashar 2014.01.06 8-29 -05.00

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(K) Number (if known)

K131461

Devioe Name LightStim for Acne Mini

Indications for Use

LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.

Prescription Use_

Over-The-Counter Use -X-

(Per 21 CFR 801. 109)

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

Conournence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden -S
2014.01-03 15:49:51
-05'00"

(Division Sign-off) for BSA

Division of Surgical Devices

510(k) Number __K131461

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.