(90 days)
The Omnilux Blue is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Omnilux Blue is a 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 415 + 5 nm. The Omnilux Blue 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.
The provided text does not contain information about specific acceptance criteria or a detailed study with performance metrics for the Omnilux Blue device. Instead, it is a 510(k) summary indicating substantial equivalence to a predicate device, the Lumenis Clearlight (K013623).
Here's a breakdown of the information that is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states: "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Therefore, the Omnilux Blue raises no new issues of safety or effectiveness." This implies that the device is considered to perform similarly to the predicate, but no specific performance metrics or acceptance criteria are provided for the Omnilux Blue itself in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable, as no specific test set data or study details are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no specific test set data or study details are provided.
4. Adjudication Method for the Test Set
Not applicable, as no specific test set data or study details are provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned. The document does not describe any MRMC studies or a comparison of human readers with and without AI assistance.
6. Standalone Performance Study
Not mentioned. No details about a standalone algorithm performance study are provided. The document outlines the physical device and its intended use.
7. Type of Ground Truth Used
Not applicable, as no specific data or study details are provided that would require a ground truth definition.
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device (LED light source) and not an AI/algorithm-based device that would typically have a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable (see point 8).
Summary of available information from the provided text:
- Device Name: Omnilux Blue
- Indication for Use: Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
- Predicate Device: Lumenis Clearlight (K013623)
- Manufacturer's Claim: Substantially equivalent to the predicate, raising no new issues of safety or effectiveness.
- FDA Determination: FDA found the device to be substantially equivalent to legally marketed predicate devices.
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JUN 1 8 2003
510(k) Summary of Safety and Effectiveness for the Photo Therapeutics Limited Omnilux Blue
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 LimitedStation HouseStamford New RoadAltrinchamCheshire WA14 1EPUnited Kingdom |
|---|---|
| Contact Person: | Maureen O'Connell5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-207-1246 |
| Summary Preparation Date: | March 18, 2003 |
- Names
Device Name:
Classification Name:
Omnilux Blue
Laser Instrument, Surgical Powered Product Code: GEX Panel: 79
3. Predicate Devices
The Omnilux Blue is substantially equivalent to the Lumenis Clearlight (K013623).
4. Device Description
The Omnilux Blue is a 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 415 + 5 nm. The Omnilux Blue 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
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K030883 2/2
the control electronics. The user interface software allows the operator to access and control all device functions.
-
- Indications for Use
The Omnilux Blue which is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
- Indications for 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. Therefore, the Omnilux Blue raises no new issues of safety or effectiveness.
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. . . . . . . . .
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Public Health Service
JUN 1 8 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: K030883 Trade/Device Name: Omnilux Blue 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: March 19, 2003 Received: March 20, 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, 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. 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 L. 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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K030883
510(k) Number (if known)
Omnilux Blue Device Name_
Indications for Use:
The Omnilux Blue is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
(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 _________________________________________________________________________________________________________________________________________________________
000012
Miriam C. Provost
(Optional Format 1-2-96) (Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030883
§ 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.