(253 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 treatment optimization, or adaptive control based on patient input.
Yes
The device's intended use is to treat mild to moderate acne on the face, which is a therapeutic action.
No
The device is intended to treat mild to moderate acne by emitting light, not to diagnose a condition. Its function is therapeutic rather than diagnostic.
No
The device description explicitly details hardware components such as an LED array assembly, selector switch, cooling arrangements, and a separate power supply.
Based on the provided information, the Omnilux Clear-U is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "treat mild to moderate acne on the face" by emitting light energy. This is a therapeutic use, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the light-emitting device and its power supply. There is no mention of analyzing biological samples (blood, urine, tissue, etc.), which is a core function of IVD devices.
- Lack of IVD-related information: The document does not contain any information typically associated with IVD devices, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnostic claims or interpretation of results.
- Performance metrics like sensitivity, specificity, etc., in the context of diagnosis.
The Omnilux Clear-U is a light therapy device intended for the treatment of a medical condition, not for diagnosing it.
N/A
Intended Use / Indications for Use
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.
Product codes (comma separated list FDA assigned to the subject device)
OLP
Device Description
The Omnilux Clear-U is a source of high spectral purity It provides uniform or "hotspot" free illumination The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth The red output of the Omnilux Clear-U is 633 + 6 nm, and the blue output is 415 ± 5 nm The Omnilux Clear-U device itself contains a selector switch (red/off/blue), the LED array assembly, and arrangements for aur cooling A separate, universal, power supply converts mains AC power to the DC power requred by the Omnilux Clear-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
face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Omnilux Clear-U 1s designed for 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)
Photo Therapeutics Limited believes that no significant differences exist between the previously approved Omnilux revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329) and the Omnilux Clear-U Therefore, the Omnilux Clear-U raises no new issues of safety or effectiveness This belief is based upon:
- An analysis of the overall performance characteristics for the device .
- The results of a self-selection test (carried out on a sample representative . population using the product labeling) which showed a mınımum comprehension rate for the critical objectives of 93% at the 95% confidence level
- The results of a usabılıty test (carried out on a sample representative population . using the product labeling) which showed a minimum comprehension rate for the critical objectives of 88% at the 95% confidence level
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K081307 Pg 1 of 2
510(k) Summary of Safety and Effectiveness for the Photo Therapeutics Limited Omnilux_Plus
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
JAN 1 6 2009
| Submitter: | Photo Therapeutics Inc
2720 Loker Avenue West
Carlsbad
California
CA 92010 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sue Darcy
CEO
Photo Therapeutics Inc
2720 Loker Avenue West
Carlsbad
California
CA 92010
Tel: 760.607.0488
Fax: 760.607.0288
Email: steve.hutson@omnilux.co.uk |
| Summary Preparation Date: | 18 th May 2007 |
| Amended: | 20 th July 2007 (Contact Person corrected) |
- Names
| Device Name: | Omnilux Clear-U |
|---|---|
| Classification Name: | Laser Instrument, Surgical Powered - General and Plastic |
| Surgery - Class II, OLP |
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 blue (K030883), Omnilux revive/Omnilux blue combination (K043329).
1
4. Device Description
The Omnilux Clear-U is a source of high spectral purity It provides uniform or "hotspot" free illumination The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth The red output of the Omnilux Clear-U is 633 + 6 nm, and the blue output is 415 ± 5 nm The Omnilux Clear-U device itself contains a selector switch (red/off/blue), the LED array assembly, and arrangements for aur cooling A separate, universal, power supply converts mains AC power to the DC power requred by the Omnilux Clear-U Treatment time is controlled by the operator
5. Indications for Use
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face The target patient population for the Omnilux Clear-U is the same as that for the predicate devices, however the Omnilux Clear-U 1s designed for home use
6. Performance Data
Photo Therapeutics Limited believes that no significant differences exist between the previously approved Omnilux revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329) and the Omnilux Clear-U Therefore, the Omnilux Clear-U raises no new issues of safety or effectiveness
This belief is based upon
- An analysis of the overall performance characteristics for the device .
- The results of a self-selection test (carried out on a sample representative . population using the product labeling) which showed a mınımum comprehension rate for the critical objectives of 93% at the 95% confidence level
- The results of a usabılıty test (carried out on a sample representative population . using the product labeling) which showed a minimum comprehension rate for the critical objectives of 88% at the 95% confidence level
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Photo Therapeutics, Inc % Ms Sue Darcy CEO 2720 Loker Avenue West Carlsbad, California 92010
Re K081307 Trade/Device Name Omnilux Clear-U 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 OLP Dated December 23, 2008 Received December 29, 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 regustration, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon
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
3
Page 2 - Ms Sue Daicy
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
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 Brometric'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 Assıstance 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. Mulhearn
Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K081307 pg 1041
Device Name
Indications for Use
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face
Prescription Use (Per 21 CFR 801 109)
で
יר
AND/OR
Over the Counter Use &
1
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081307