SKIN CARE LIGHT by TRANSVERSE INDUSTRIES CO.

Skin Care Light is intended to provide phototherapeutic light to the face. It is used to treat dermatological conditions by exposing the surface of the skin to the blue spectrum. It is specifically indicated to treat moderate inflammatory acne vulgaris.

Device Description

Skin Care Light is a lamp intended to treat dermatological conditions by emitting visible light in blue and/or red.The energy intensity are 4,8,12mW/c m².The system includes a spectral band light source and some controlling keys to select light.It also includes mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area,an electronic unit to control the duration,it will automatically shut off after 15 minutes.

AI/ML Overview

The provided text is a 510(k) summary for the "Skin Care Light" device. It outlines the device's classification, intended use, and a statement of substantial equivalence to a predicate device. However, this document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with predefined acceptance criteria for novel claims. The provided text indicates the device is substantially equivalent to the "ClearLight Phototherapy Device, Model CL 420 (K013623)". The FDA's letter (pages 3-4) confirms this determination based on the information submitted.

Therefore, many of the requested details about acceptance criteria, study sample sizes, expert involvement, and ground truth establishment are not present in this kind of 510(k) summary document for substantial equivalence.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria: Not explicitly stated in terms of performance metrics for the "Skin Care Light" device itself. The primary "acceptance criterion" for the 510(k) submission was demonstrating substantial equivalence to the ClearLight Phototherapy Device.
Reported Device Performance:
- Energy Intensity: 4, 8, 12 mW/cm² (for light emitted).
- Light Spectrum: Visible light in blue and/or red spectrum.
- Duration Control: Automatically shuts off after 15 minutes.
- Intended Use: To treat moderate inflammatory acne vulgaris.
  
  It's important to note that these are device specifications and intended use, not performance metrics against a defined acceptance criterion for efficacy from a specific study within this document.

2. Sample size used for the test set and the data provenance:

Not explicitly stated in this document. A 510(k) summary demonstrating substantial equivalence typically references the predicate device's performance data rather than conducting new, large-scale clinical trials for the new device. If a performance study was conducted for the "Skin Care Light," its details are not in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not stated in this document. Since no explicit performance study with a 'test set' for the "Skin Care Light" is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not stated in this document.

5. 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:

Not applicable. This device is a light therapy device, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

Not applicable. This is a hardware light therapy device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not stated for the "Skin Care Light." For substantial equivalence, the "ground truth" implicitly relies on the predicate device's established safety and effectiveness. If the predicate device (ClearLight Phototherapy Device) had clinical studies to support its claims, those would have used some form of ground truth (e.g., clinical assessment by dermatologists, lesion counts, etc.), but this isn't detailed for the "Skin Care Light" itself in this document.

8. The sample size for the training set:

Not applicable/Not stated. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable/Not stated.

In summary: The provided 510(k) summary focuses on demonstrating that "Skin Care Light" is substantially equivalent to a predicate device (ClearLight Phototherapy Device, Model CL 420, K013623) based on its intended use and general technological characteristics. It does not contain the detailed performance study data, acceptance criteria, or ground truth establishment that would be present for a novel device undergoing extensive clinical trials or an AI/machine learning device. The "proof" is the FDA's determination of substantial equivalence, allowing it to be marketed for the stated indications.

Summary

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510(k) Summary as required by section KO70870 807.92(c)

007 ) 0 2007

Submitted by:TRANSVERSE INDUSTRIES CO.

NO.305 HUA CHENG RD.HSIN-CHUANG

CITY TAIPEI,TAIWAN R.O.C.

TEL:886-2-85218692

FAX:886-2-85216662

Contact Person: HO KO LIANG

Prepared On : April 02,2007

K24

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Classification Name : Laser Instrument,Surgical Powered.

Common or Usual name: Light Therapy Device

Proprietary Name: Skin Care Light

Classification : The subject device satisfies the 21 CFR definition of a class 2

,Laser surgical instrument for use in general and plastic

RegulationNumber	Product Code	Regulation Name	ReviewPanel
878.4810	GEX	Laser surgical instrument for usein general and plastic surgery andin dermatology.	General &PlasticSurgery

surgery and in dermatology as follows :

Substantial Equivalence :

Skin Care Light is substantially equivalence with the ClearLight Phototherapy Device,Model CL 420 ( K013623 ) made in Israel.Skin Care Light has the equivalent intended use and different technological characteristics.

Device Description :

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mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area,an electronic unit to control the duration,it will automatically shut off after 15 minutes.

Statement of Indication For Use :

Skin Care Light is intended to provide phototherapeutic light to the body.It is generally indicated to treat dermatological conditions. Skin Care Light is specifically indicated to treat moderate inflammatory acne vulgaris.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted as a staff with a serpent entwined around it, representing healing and medicine. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Transverse Industries Company % Mr. Ho Ko Liang President No. 305 Hua Cheng Road Hsin-Chuang City, Taipei, China (Taiwan)

Re: K070870 Trade/Device Name: Skin Care Light Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 18, 2007 Received: September 18, 2007

Dear Mr. Liang:

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.

OCT 1 0 2007

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the

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Page 2 - Mr. Ho Ko Liang

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours. Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND/GSDB D.O. f/t:KSB:kxl:10-04-07

OC Numbers:

Division of Enforcement A	240-276-0115
Dental, ENT and Ophthalmic Devices Branch	240-276-0115
OB/GYN, Gastro. & Urology Devices Branch	240-276-0115
General Hospital Devices Branch	240-276-0115
General Surgery Devices Branch	240-276-0115
Division of Enforcement B	240-276-0120
Cardiovascular & Neurological Devices Branch	240-276-0120
Orthopedic. Physical Medicine & Anesthesiology Devices Br.	240-276-0120

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Indications for Use

510(k) Number ( if known ) : K070870 Device Name : Skin Care Light Indication For Use :

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ( Part 21 CFR 801 Subpart D )

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ ( Part 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)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	K020680

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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.