The ClearLight Phototherapy System is intended to provide phototherapeutic light to the body. The ClearLight is generally indicated to treat dermatological conditions. The ClearLight is specifically indicated to treat moderate inflammatory acne vulgaris.

Device Description

The ClearLight Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as acne vulgaris by emitting visible light in the violet-blue range with fluency of light ranging between 50-200 mW/cm². The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and an optical system for controlling spectra and beam parameters of the light source. It also includes a 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, and power of the emitted radiation and to capture and store patient data via a touch screen (i.e., control console), and a camera for capturing digital images.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no explicitly stated numerical acceptance criteria or quantitative performance metrics for the ClearLight Phototherapy device. The substantial equivalence determination is made against predicate devices, which suggests that the "acceptance criteria" here are qualitative and focused on safety and effectiveness being similar to already marketed devices for the stated indication.

However, we can infer the primary performance goal: Demonstrate safety and effectiveness for treating moderate inflammatory acne vulgaris.

Acceptance Criteria (Inferred)	Reported Device Performance
Safety: Device is safely used for dermatological conditions.	- Preclinical testing: Electrical Safety and EMC testing (IEC 60601-1, EN 55011, IEC 60601-1-2), Photobiological Safety (ANSI/ESNA RP-27 1-96, RP-27.3-96). Results indicate compliance with these safety standards.
Effectiveness: Device is effective in treating moderate inflammatory acne vulgaris.	- In vitro testing: Demonstrated eradication of P. acnes by endogenous porphyrins when exposed to high-intensity narrow-band light. - Clinical data: "Clinical data from the trial of the ClearLight device for the treatment of dermatological conditions supports substantial equivalence and demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris."
Substantial Equivalence: Comparable to predicate devices in intended use, indications for use, and technological characteristics without raising new safety/efficacy questions.	Stated to be substantially equivalent to listed predicate devices (Phototherapeutix, Derma-Wand, XTrac Excimer Laser System, Wallaby 3 Phototherapy System) based on similar intended use, general indications, and principles of operation. Differences in technological characteristics "do not raise new questions of safety or efficacy."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for the Test Set: Not mentioned. The document only references "Clinical data from the trial of the ClearLight device." The specific number of patients or cases in this clinical trial is not provided.
Data Provenance: Not explicitly stated, but the submitter (CureLight Ltd.) is located in Or Akiva, Israel. The study likely originated from Israel, but this is an assumption. The document does not specify if it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

Adjudication Method: Not mentioned.

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:

MRMC Study: No, this is not an AI-assisted diagnostic device, but rather a phototherapy system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

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

Standalone Performance: Not applicable. This is a phototherapy device, not an algorithm. The "performance" refers to its physical therapeutic effects rather than algorithmic output.

7. The Type of Ground Truth Used:

Ground Truth: The document states that "Clinical data from the trial... demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris." This implies that the ground truth for effectiveness was likely based on clinical outcomes observed in patients (e.g., reduction in lesion count, physician global assessment of acne severity, or patient-reported outcomes for acne treatment). The "in vitro testing" provided biological evidence (eradication of P. acnes) which supports the mechanism of action but isn't the primary clinical ground truth.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This is not a machine learning device that requires a training set in the conventional sense. The "training" here would be the development and testing of the physical phototherapy system itself (e.g., optimizing light parameters), rather than training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set Was Established: Not applicable, as it's not an AI/ML device requiring a training set with established ground truth.

Summary

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8/16/02

510(k) SUMMARY

CureLight's ClearLight Phototherapy Device (K013623)

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel.

Phone:	+972 (52) 691764
Facsimile:	+972 (4) 8374897

Dr. Yoram Harth Contact Person:

August 7, 2002 Date Prepared:

Name of Device and Name/Address of Sponsor

ClearLight Phototherapy Device, Model CL 420

CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel

Common or Usual Name

Light Therapy Device

Classification Name

Ultraviolet Dermatological Light

Predicate Devices

Avex Industries, Inc.'s Phototherapeutix National Biological Corporation's Derma-Wand PhotoMedex, Inc.'s XTrac Excimer Laser System, Model AL 7000 Respironics, Inc.'s Wallaby 3 Phototherapy System

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Kc13623 2/3

Intended Use / Indications for Use

Technological Characteristics

Performance Data

The preclinical testing includes Electrical Safety and EMC testing, including the requirements of IEC 60601-1 "Medical Electrical Equipment Part 1 - General Requirements for Safety" and was tested in accordance to Medical Directive 93/42/EEC - EN 55011: 1998 + A1(99). Class A and IEC 60601-1-2 "Collateral Standard: Medical El'ectrical Equipment Electromagnetic Compatibility - Requirements and Tests." ANSI/ESNA RP-27 1-96 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements ANSI/ESNA RP-27.3-96 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification Labeling.

In vitro testing demonstrated that exposure to high intensity narrow band light induced eradication of p. acnes by endogenic porphyrins.

Clinical data from the trial of the ClearLight device for the treatment of dermatological conditions supports substantial equivalence and demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris.

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Koi 3623 3/3

Substantial Equivalence

CureLight's ClearLight is substantially equivalent to other legally marketed Ultraviolet Dermatological Light devices. The ClearLight has the same intended use and general indications for use, and similar principles of operation and technological characteristics as the previously cleared predicate Avex Industries Ltd.'s Phototherapeutix devices; National Biological Corporation's Derma-Wand; PhotoMedex, Inc.'s XTrac Excimer Laser System, Model AL 7000; and Respironics Inc.'s Wallaby 3 Phototherapy System. In addition, the ClearLight's specific indication for use in subsumed within the general indications for use and encompassed by the specific indications for use of its predicate devices.

The ClearLight and its predicate devices are all light device that are used to treat dermatological conditions by exposing the surface of the skin to light at precise wavelengths. Although there are differences in the technological characteristics of the ClearLight and its predicate devices, those differences do not raise new questions of safety or efficacy. Thus, the ClearLight is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized graphic of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, abstract design. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Curclight, LTD c/o Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Rc: K013623

Trade/Device Name: Clearlight Phototheraphy System, Model CL 420 Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: May 23, 2002 Received: May 23, 2002

Dear Mr. Kahan:

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.

If your device is classified (see above) into cither 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 docs 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 setforth 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.

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Page 2 -- Mr. Jonathan S. Kahan

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrlv/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ClearLight Phototherapy Device

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aller Tall (Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number C013623

Prescription Use _ A (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_ (Optional Format 1-2-96)

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.