The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.

Device Description

The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¾" square patch of skin without exposure to neighboring, healthy tissues.

AI/ML Overview

The provided text is a 510(k) summary for the TheraLight UV120-2 UVA / UVB Phototherapy System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study against a specified ground truth.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) cannot be answered from the provided document as they are not included.

Here's a summary of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics. Instead, it states that "System performance data (UVB output spectra) is the same or very similar that for the claimed predicate devices." This implies that the acceptance criterion was likely substantial equivalence in its UVB output spectra to the predicate devices, rather than meeting specific quantifiable clinical performance thresholds.

Acceptance Criteria	Reported Device Performance
Substantially equivalent UVB output spectra to predicate devices	"Same or very similar" UVB output spectra as predicate devices

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

Not applicable. No specific "test set" in the context of a clinical performance study is mentioned. The assessment was based on comparing device specifications, particularly UVB output spectra, with predicate devices.

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

Not applicable. Ground truth as typically understood for diagnostic or prognostic devices (e.g., expert consensus on images, pathology results) was not established. The comparison was against predicate device specifications.

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

Not applicable. No test set adjudication method is 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:

No. This device is a phototherapy system, not an AI-assisted diagnostic or imaging device for which MRMC studies would be relevant.

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

Not applicable. This device is a phototherapy system, not an algorithm. Its performance is based on its physical output.

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

The "ground truth" implicitly used for comparison was the UVB output spectra of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

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

Not applicable.

Summary

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024020

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JAN 1 7 2003

510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's name:	TheraLight, Inc.
Submitter's Address:	2794 Loker Avenue West, Suite 105Carlsbad, CA 92008-6616
Telephone:	(760) 930-8000
Contact:	Kevin E. Daly
Date Prepared:	December 2, 2002
Device Trade Name:	UV120-2 UVA / UVB Phototherapy System
Device Common Name:	Targeted UVA / UVB Phototherapy System
Device Classification Name:	Ultraviolet lamp for dermatologic / skindisorders (ref. 21 CFR 878.4630)
Predicate Devices:	TheraLight, Inc.UV120-2 UVA / UVB Phototherapy SystemK022165
	Lumenis, Ltd.BClear UVB Phototherapy SystemK020591
	PhotoMedex, Inc.XTRAC Excimer Laser Phototherapy System

K020847

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K024020

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Device Description:

Intended Use:

The TheraLight UV120-2 UVA / UVB Phototherapy System is intended for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.

Performance Data:

The TheraLight UV120-2 UVA / UVB Phototherapy System currently is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema) and seborrheic dermatitis. System performance data (UVB output spectra) is the same or very similar that for the claimed predicate devices.

Conclusion:

On the basis of the information provided in this Summary, TheraLight, Inc. believes the UV120-2 UVA / UVB Phototherapy System is substantially equivalent to legally commercialized predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Theralight, Inc. Kevin E. Daly Chief Operating Officer 2794 Loker Avenue West, Suite 105 Carlsbad, California 92008-6616

Re: K024020

Trade/Device Name: UV120-2 UVA/UVB Phototherapy System Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic/skin disorders Regulatory Class: Class II Product Code: FTC Dated: December 3, 2002 Received: December 5, 2002

Dear Mr. Daly:

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 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

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Page 2 -- Mr. Kevin E. Daly

(21 CFR Part 807); labeling (21 CFR Part 801); 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. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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Page | of |

510(k) Number (if known): 上のスイリ20

Device Name: TheraLight UV120-2 UVA/UVB Phototherapy System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Optional Format 3-10-98)

ivision Sign-Off Jivision of General, Restorative and Neurological Devices

K024020

Regulation Number and Section

§ 878.4630 Ultraviolet lamp for dermatologic disorders.

(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.