(190 days)
No
The device description focuses on light emission and control, with no mention of AI/ML terms or functionalities like image processing, data analysis for diagnosis, or adaptive treatment based on patient data.
Yes
The device is intended for "treatment of periorbital wrinkles," which signifies a therapeutic purpose.
No
The device is intended for treatment (emission of energy for the treatment of periorbital wrinkles), not for diagnosis.
No
The device description clearly outlines physical hardware components including LED heads, a base unit with power supplies and control unit, folding arms, an LCD, and a keyboard, indicating it is not software-only.
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 periorbital wrinkles" using light energy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device emits light energy and is used for patient treatment. It does not involve testing samples from the human body (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample handling, or analysis of biological specimens.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a therapeutic device that applies light energy directly to the patient's skin.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX, ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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 Limited
Station House
Stamford New Road
Altrincham
Cheshire WA14 1EP
United Kingdom |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Steve Hutson
Director of Engineering and Regulatory
Affairs
Photo Therapeutics Limited
Station House
Stamford New Road
Altrincham
Cheshire WA14 1EP
United Kingdom
T: +44 161 925 5615
F: +44 161 925 5628 |
| Summary Preparation Date: | December 10th, 2004 |
| Device Name: | Omnilux Revive and Omnilux Plus
Combination |
| Classification Name: | Omnilux Revive - Laser Instrument,
Surgical Powered - General and Plastic
Surgery - Class II, 79-GEX
Although this device is not a laser, the
manufacturer thinks this is the closest
applicable classification name.
Omnilux Plus - Lamp, Infrared - Physical
Medicine - Class II, 89-ILY, 890.5500 |
1
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.
2
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.
3
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
4
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