(157 days)
Not Found
No
The device description focuses on the light source technology and control unit, with no mention of AI or ML terms, image processing, or data sets for training/testing.
Yes
Explanation: The device is indicated for treatment of superficial, benign vascular, and pigmented lesions, which is a therapeutic purpose.
No
The device is described as a treatment device for superficial, benign vascular, and pigmented lesions, providing "illumination" and "patient treatment." There is no mention of it being used to identify, measure, or observe medical conditions or diseases.
No
The device description clearly states it includes hardware components such as a base unit, power supplies, control unit, folding arms, and an LED head. While it mentions user interface software, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of superficial, benign vascular, and pigmented lesions" in dermatology. This describes a therapeutic application, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device is described as an "intense visible light source" used for treatment. It applies light to the patient's skin. IVDs typically involve analyzing samples (like blood, urine, or tissue) outside the body.
- No mention of analyzing samples: There is no mention of the device collecting or analyzing any biological samples from the patient.
- No mention of diagnostic purpose: The entire description focuses on the therapeutic application of light for treatment.
Therefore, the Omnilux Revive, as described, is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Omnilux Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Limited
Station House
Stamford New Road
Altrincham
Cheshire WA14 1EP
United Kingdom |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-207-1246 |
| Summary Preparation Date: | May 6, 2003 |
| 2. | Names |
| Device Name: | Omnilux Revive |
| Classification Name: | Laser Instrument, Surgical Powered
Product Code: GEX
Panel: 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
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
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.
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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.
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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
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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)
OR
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