(185 days)
No
The device description and performance studies focus on the light emission properties and comparison to predicate devices, with no mention of AI/ML technologies or data processing.
Yes
The device is intended to treat a medical condition (periorbital wrinkles) and emits energy for this purpose.
No
The device is intended to emit light to treat periorbital wrinkles, not diagnose them. Its function is therapeutic (treatment), not diagnostic (identification or assessment of a condition).
No
The device description explicitly details hardware components such as an LED array assembly, selector switch, air cooling arrangements, and a separate power supply, indicating it is a physical device that emits light, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Omnilux New-U Function: The description clearly states the Omnilux New-U is a device that emits light energy (red and IR) to treat periorbital wrinkles. It interacts directly with the skin.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples. Its function is based on delivering light therapy to the skin.
The device description and intended use clearly indicate it is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum, specifically indicated to reduce periorbital wrinkles. The target patient population for the Omnilux New-U is the same as that for the predicate devices, however the Omnilux New-U is designed for home use.
The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Product codes
OHS
Device Description
The Omnilux New-U is a source of high spectral purity. It provides uniform or "hot-spot" free illumination. The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth. The red output of the Omnilux New-U is 633 + 6 nm, and the IR output is 830 ± 5 nm. The Omnilux New-U device itself contains a selector switch (red/off/IR), the LED array assembly, and arrangements for air cooling. A separate, universal, power supply converts mains AC power to the DC power required by the Omnilux New-U. Treatment time is controlled by the operator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital (wrinkles)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use.
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 device. Photo Therapeutics Limited believes that no significant differences exist between the previously approved Omnilux revive (K030426), Omnilux plus (K043317), Omnilux revive/Omnilux plus combination (K050216) and the Omnilux New-U. Therefore, the Omnilux New-U raises no new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Omnilux Revive (K030426), Omnilux plus (K043317), Omnilux revive/Omnilux plus combination (K050216)
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 Therapeutics Limited Omnilux New-U
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 Inc
2720 Loker Avenue West
Carlsbad
California
CA 92010 |
| ------------ | ---------------------------------------------------------------------------------------- |
|---|
| Contact Person: | Sue Darcy |
|---|---|
| Chief Executive Officer | |
| Photo Therapeutics Inc | |
| 2720 Loker Avenue Wes- | |
| Carlsbad | |
| California | |
| CA 92010 |
Summary Preparation Date: 8th August 2007
2. Names
| Device Name: | Omnilux New-U |
|---|---|
| Classification Name: | Laser Instrument, Surgical Powered - General and Plastic |
| Surgery - Class II, 79-GEX |
Although this device is not a laser and is intended for OTC use, the manufacturer thinks this is the closest applicable classification name.
3. Predicate Devices
Omnilux Revive (K030426), Omnilux plus (K043317), Omnilux revive/Omnilux plus combination (K050216).
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Device Description 4.
The Omnilux New-U is a source of high spectral purity. It provides uniform or "hot-spot" free illumination. The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth. The red output of the Omnilux New-U is 633 + 6 nm, and the IR output is 830 ± 5 nm. The Omnilux New-U device itself contains a selector switch (red/off/IR), the LED array assembly, and arrangements for air cooling. A separate, universal, power supply converts mains AC power to the DC power required by the Omnilux New-U. Treatment time is controlled by the operator.
5. Indications for Use
The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum, specifically indicated to reduce periorbital wrinkles. The target patient population for the Omnilux New-U is the same as that for the predicate devices, however the Omnilux New-U is designed for home use.
6. Performance Data
Based upon an analysis of the overall performance characteristics for the device. Photo Therapeutics Limited believes that no significant differences exist between the previously approved Omnilux revive (K030426), Omnilux plus (K043317), Omnilux revive/Omnilux plus combination (K050216) and the Omnilux New-U. Therefore, the Omnilux New-U raises no new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, rendered in a thick, black line. The eagle's head is turned to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Photo Therapeutics, Inc. % Ms. Sue Darcy Chief Executive Officer 2720 Loker Avenue West Carlsbad, California 92010
MAR - 3 2008
Re: K072459
Trade/Device Name: Omnilux New-U Regulatory Number: 21 CFR 878.4810 Regulatory Name: Light based over the counter wrinkle reduction Regulatory Class: II Product Code: OHS Dated: January 22, 2008 Received: January 24, 2008
Dear Ms. Darcy:
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 (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. Sue Darcy
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 -- Ms. Sue Darcy
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 (DGRND/GSDB) D.O. f/t:KSB:tlm:1-28-08
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
OC Numbers:
| Division of Enforcement A | 240-276-
0115 |
|------------------------------------------------------------------------------------|------------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-
0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-
0115 |
| General Hospital Devices Branch | 240-276-
0115 |
| General Surgery Devices Branch | 240-276-
0115 |
| Division of Enforcement B | 240-276-
0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-
0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices and
Radiological Devices | 240-276-
0120 |
Last Updated: Brandi Stuart – 7/9/07
5
Omnilux New-U Device Name___________
Indications for Use:
The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Prescription Use (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)
Nath
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number l072455