(190 days)
The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
The Omnilux Revive and Omnilux Plus are two sources of high spectral purity. They provide uniform or "hot-spot" free illumination. The outputs are pre-tuned to one wavelength with a narrow spectral bandwidth. The output of the Omnilux Revive is 633 + 5 nm, and the output of the Ommilux Plus is 830 + 5 nm. The 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 ams and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control clectronics. The user interface software allows the operator to access and control all device functions.
The provided 510(k) summary for the Omnilux Revive and Omnilux Plus Combination device does not include information about acceptance criteria or a study that proves the device meets specific performance metrics.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K030426 for Omnilux Revive and K043317 for Omnilux Plus). The argument is that because the combination device comprises two components previously deemed safe and effective, and no significant differences exist, it raises no new issues of safety or effectiveness.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be stated based on the given document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not define specific performance acceptance criteria or report performance against such criteria. The device's "performance data" section states: "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist between the Omnilux Revive and the Omnilux Plus Combination, the previously approved Omnilux Revive (K030426) and the Omnilux Plus (which is the subject of 510K submission K043317). Therefore, the Omnilux Revive and Omnilux Plus Combination raises no new issues of safety or effectivencss."
2. Sample size used for the test set and the data provenance
Not applicable. No new study for the combined device is described that would involve a test set. The submission relies on the substantial equivalence of its components to previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new study for the combined device is described that would involve a test set requiring ground truth establishment by experts.
4. Adjudication method for the test set
Not applicable. No new study for the combined device is described that would involve adjudication.
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 not an AI-based diagnostic tool, but rather a light therapy device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used
Not applicable. No new study requiring ground truth is described.
8. The sample size for the training set
Not applicable. This submission is not for an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device requiring a training set.
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510(k) Summary of Safety and Effectiveness for the Photo Therapoutics Limited Omnilux Plus
This 510(k) Summary of Safety and Ellcctiveness 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: | Steve HutsonDirector of Engineering and RegulatoryAffairsPhoto Therapeutics LimitedStation HouseStamford New RoadAltrinchamCheshire WA14 1EPUnited KingdomT: +44 161 925 5615F: +44 161 925 5628 |
| Summary Preparation Date: | December 10th, 2004 |
| Device Name: | Omnilux Revive and Omnilux PlusCombination |
| Classification Name: | Omnilux Revive - Laser Instrument,Surgical Powered - General and PlasticSurgery - Class II, 79-GEXAlthough this device is not a laser, themanufacturer thinks this is the closestapplicable classification name.Omnilux Plus - Lamp, Infrared - PhysicalMedicine - Class II, 89-ILY, 890.5500 |
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so216
3. Predicate Devices
Predicate devices for the Omnilux Revive and the Omnilux Plus were detailed in ; K030426 and 510K submission K043317 respectively.
4. Device Description
The Omnilux Revive and Omnilux Plus are two sources of high spectral purity. They provide uniform or "hot-spot" free illumination. The outputs are pre-tuned to one wavelength with a narrow spectral bandwidth. The output of the Omnilux Revive is 633 + 5 nm, and the output of the Ommilux Plus is 830 + 5 nm. The 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 ams and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control clectronics. The user interface software allows the operator to access and control all device functions.
5. Indications for Use
The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the rod and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Performance Data 6.
Based upon an analysis of the overall performance characteristics for the dovice, Photo Therapeutics Limited believes that no significant differences exist between the Omnilux Revive and the Omnilux Plus Combination, the previously approved Omnilux Revive (K030426) and the Omnilux Plus (which is the subject of 510K submission K043317). Therefore, the Omnilux Revive and Omnilux Plus Combination raises no new issues of safety or effectivencss.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
AUG 9 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Hutson Director of Engineering and Regulatory Affairs Photo Therapeutics Limited Station House, Stamford New Road Altrincham Cheshire WA 14 1EP United Kingdom
Re: K050216
Trade/Device Name: Omnilux Revive and Omnilux Plus Combination 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: June 16, 2005 Received: June 22, 2005
Dear Mr. Hutson:
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 for association 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 (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.
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Page 2- Mr. Steve Hutson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to ocgin mailoung of substantial equivalence of your device to a legally premaired predicated 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 If you desire specific acrroliance at (240) 276-0115. Also, please note the regulation entitled, Conact the Office of Compulance as (21 t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionation on 900 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,
Barbara Buekins
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Omnilux Revive and Omnilux Plus Combination Device Name_
Indications for Use: 《ζΟΣΟΣΟΣΟΣΟΣ
The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Prescription Use _X (Per 21 CFR 801.109)
AND/OR
Over The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Boutwell Buchard for Mark Meiterson
al. Restorative and Neurological Devic
510(k) Number
§ 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.