The Omnilux Revive is an intense visible light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength is 633 ± 5 nm. The Omnilux Revive base unit contains the power supplies and the control unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.

AI/ML Overview

The provided text for K030426, "510(k) Summary of Safety and Effectiveness for the Photo Therapeutics Limited Omnilux Revive," does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document indicates that the submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance against predefined acceptance criteria through new clinical studies.

Here's a breakdown of why this information is missing based on the provided text:

No detailed performance data: Section 6, titled "Performance Data," explicitly states: "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Therefore, the Omnilux Revive raises no new issues of safety or effectiveness." This statement refers to a comparison with predicate devices, not a new study with acceptance criteria.
Reliance on substantial equivalence: The FDA letter (page 2-3) confirms the review is for a 510(k) premarket notification and that the device is deemed "substantially equivalent" to predicate devices. This regulatory pathway primarily assesses if a new device is as safe and effective as a legally marketed one, without necessarily requiring new clinical trials to establish de novo performance metrics.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this document.

However, based on the principle of substantial equivalence, the implicit "acceptance criteria" are that the device's performance characteristics (e.g., wavelength, spectral purity, indication for use) are comparable to established predicate devices.

Here's what can be inferred or stated as absent:

Table of acceptance criteria and reported device performance:

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices)	Reported Device Performance (from K030426)
Wavelength and Spectral Purity (comparable to predicate devices)	Output wavelength: 633 ± 5 nm; Narrow spectral bandwidth
Intended Use (comparable to predicate devices)	Indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.
Safety and Effectiveness (comparable to predicate devices)	"no significant differences exist," "raises no new issues of safety or effectiveness."

Note: The document
does not explicitly state numerical acceptance criteria nor does it provide a formal comparison table against such criteria. The reported performance is what the device claims to output.

Sample size used for the test set and the data provenance: Not applicable. No test set or associated study is described in the provided 510(k) summary for establishing new performance metrics. The submission relies on existing data/knowledge of predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
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 source for dermatological treatment, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a hardware light source, not an algorithm.
The type of ground truth used: Not applicable. No new ground truth was established for this submission. The basis is substantial equivalence to legally marketed predicate devices, which would have had their safety and effectiveness established through prior means (e.g., clinical evidence, recognized standards).
The sample size for the training set: Not applicable. This device is a medical device (light source) that seeks substantial equivalence based on its physical characteristics and intended use, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable. See point 8.

Summary

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

K030426

JUL 17 2003 510(k) Summary of Safety and Effectiveness for the Photo Therapeutics Limited Omnilux Revive

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:	Photo Therapeutics LimitedStation HouseStamford New RoadAltrinchamCheshire WA14 1EPUnited Kingdom
Contact Person:	Maureen O'Connell5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-207-1246
Summary Preparation Date:	May 6, 2003
2.	Names
Device Name:	Omnilux Revive
Classification Name:	Laser Instrument, Surgical PoweredProduct Code: GEXPanel: 79

3. Predicate Devices

The Omnilux Revive is substantially equivalent to a combination of the following devices: the IPL Quantum SR manufactured by Lumenis, Inc. and subject of K020839; the Aurora SR manufactured by Syneron Medical Ltd. and subject of K022266; and the EsteLux manufactured by Palomar Medical Technologies, Inc. and subject of K020453.

4. Device Description

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

unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.

5. Indications for Use

The Omnilux Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

Performance Data 6.

Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Therefore, the Omnilux Revive raises no new issues of safety or effectiveness.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

JUL 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Photo Therapeutics Limited c/o Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K030426 Trade/Device Name: Omnilux Revive 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: May 6, 2003 Received: May 8, 2003

Dear Ms. O'Connell:

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. Iisting 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 (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.

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

Page 2 - Ms. Maureen O'Connell

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. 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" (21CFR Part 807.97) you may obtain. 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam 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

{4}------------------------------------------------

510(k) Number K030426

Device Name _________ Revive

Indications for Use:

The Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

(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)

Over The Counter Use

Miriam C. Provost(Optional Format 1-2-96)

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

510(k) Number K030426

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.