(106 days)
No
The summary describes a light therapy device with specific wavelengths and controls, with no mention of AI or ML in its function or intended use.
Yes
The device is intended to "treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris," which describes a therapeutic use.
No
The device is intended to treat dermatological conditions, specifically mild to moderate acne vulgaris, by emitting energy in the red and blue regions of the spectrum. It does not mention any function for diagnosing conditions.
No
The device description clearly details hardware components such as light sources, a base unit, arms, an LCD, and a keyboard, indicating it is a physical device, 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 to "treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris." This describes a therapeutic treatment applied directly to the patient's skin, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a light-emitting device used for treatment, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device applies light energy externally.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
The Omnilux Revive and Blue Combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Omnilux Revive and Blue is a combination of two sources of high spectral purity. They provide uniform or "hot-spot" headwidth. The output pre-tuned to one wavelength with a narcow spectral bandwidth: Rlue is 415 + 2 pre-tuned to one wavelength with a nation specular Blue is 415 + 5m. wavelength of Omnilux Revive is 63 + 5 mm, and Omnilux Blue is 415 + 5m. wavelength of Ommilux Revive Is 055 ± 3 min, in supplies and the control unit. Attached The Omnilux base unit contains the power expenses . The control unit consists on to the base unit are inree foruing annis. The econtrol unit consists of the arms and then positioned for patient to the lesting. The user interface of the arms and then positioned for parterials. The user interface an LCD and keyboard together with the control devices functions an LCD and Reyboard together while the reasonal 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 (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 Omnilux Revive (K030426) and Omnilux Blue (K030883) devices and their Omnilux Revive and Blue Combination raises no new issues of safety or effectiveness.
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.
K020839, K022266, K020453, K013623
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
K043329 1 of 2
MAR 1 8 2005
510(k) Summary of Safety and Effectiveness for the STO(R) Suinmal y of Survey and Revive and Blue Combination
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with a
reas and Effective 1000 mm 1.01 Climp 207 02 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 |
| | Summary Preparation Date: | November 17th, 2004 |
| 2. | Names | |
| | Device Name: | Omnilux Revive and Blue Combination |
| | Classification Name: | Laser Instrument, Surgical powered
Product Code: GEX
Panel: 79 |
3. Predicate Devices
Predicates for the Omnilux Revive and Omnilux Blue were detailed in K030426 and K030883 respectively, but the predicates are listed below for completeness.
Omnilux Revive is substantially equivalent to ... IPL Quantum SR manufactured by Lumenis, Inc. (K020839) Aurora SR manufactured by Syneron Medical Ltd.(K022266) EsteLux manufactured by Palomar Medical Technologies, Inc. (K020453)
1
2 K043329
Omnilux Blue is substantially equivalent to ... Lumenis ClearLight (K013623).
4. Device Description
The Omnilux Revive and Blue is a combination of two sources of high spectral
ed the outs of the count the tast the supplies of the two output a The Omnilux Revive and Blue is a compination. The two output are
purity. They provide uniform or "hot-spot" headwidth. The output purity. They provide unitoin of the spectral bandwidth. The output
pre-tuned to one wavelength with a narcow spectral bandwidth: Rlue is 415 + 2 pre-tuned to one wavelength with a nation specular Blue is 415 + 5m.
wavelength of Omnilux Revive is 63 + 5 mm, and Omnilux Blue is 415 + 5m. wavelength of Ommilux Revive Is 055 ± 3 min, in supplies and the control unit. Attached
The Omnilux base unit contains the III I FD hose same attached to the end The Omnilux base unit contains the power expenses . The control unit consists on to the base unit are inree foruing annis. The econtrol unit consists of
of the arms and then positioned for patient to the lesting. The user interface of the arms and then positioned for parterials. The user interface
an LCD and keyboard together with the control devices functions an LCD and Reyboard together while the reasonal control all device functions.
5. Indications for Use
The Omnilux Revive and Blue Combination is intended to emt energy in the red The Omninux Revive and Drac Contrainer
and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
6. Performance Data
Based upon an analysis of the overall performance characteristics for the device, Based upon an analysis of the overal pot no significant differences exist between
Photo Therapeutics Limited believes that no significant differences exist between Photo Therapedites Enmited Seneves ination' and the previously approved the Onlinex Revive (K030426) and Omnilux Blue (K030883) devices and their Omnilux Revive (R050+20) and Onlines Revive and Blue Combination raises no new issues of safety or effectiveness.
The new intended use is detailed in Appendix 1.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Hutson MI. Btoroff Engineering and Regulatory Affairs Photo Therapeutics Ltd. Station House Stamford New Road Altrincham Cheshire WA14 1EP United Kingdom
Re: K043329
K043329
Trade/Device Name: Omnilux Revive and Blue 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: February 1, 2005 Received: February 7, 2005
Dear Mr. Hutson:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section - ro(x) premained is substantially equivalent (for the indications referenced above and nave determined the acteed predicate devices marketed in interstate for use stated in the enclosure) to regary manced provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Foderal Food. Drug commerce prior to May 20, 1970, the charment and be provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provision application (PM devices that have been recassified in acceraated in a premarket approval applications (PMA).
and Cosmetic Act (Act) that do not require approval or suisions of the Act . The and Cosment Act (Act) that to hot require approvince so the general controls, provisions of the Act. The You may, merelore, market the device, saojost to annual registration, listing of
general controls provisions of the Act include requirements for annual registration, word general controls provisions of the Act merade requires.
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 class If your device is classified (SCC above) nike existing mass regulations affecting your device can
may be subject to such additional controls. Existing may of a policy and th may be subject to such additional controller in thisting in your and to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Code of Pederal Regaring your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualler of a substance organics with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemmanon alae Jour are Jour accred by other Federal agencies. You must li or any Federal statures and regulations adminting, but not limited to: registration and listing ( 2 l
ever state all the Act's requirements, including, but not limited to: se comply with an the Act s requirements, mercanse, a
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice also akatest CFK Part 807), labeling (21 CFR Part 800), government (20); and if applicable, the electronic forth in the quality systems (QU) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
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 will anow you to begin maneting of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalse and the p premarket notification. The PDA miding of substantal equive 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
r and the may be and 115 and has and any and as a the requiries weritled If you desire specific advice for your at 110 mm. Also, please note the regulation cutitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the open ob contact the Office of Compliance at (210) 276 or 1 (21CFR Part 807.97). You may obtain " Misbranding by reference to premance notification of Set from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 638other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assibuner as to to to to to to to the new support/index.html.
Sincerely yours.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letters 'K' and 'O', followed by the numbers '4', '3', '3', '2', and '9'. The characters are written in a dark ink, and the handwriting appears somewhat casual.
Omnilux Revive and Blue Combination_ Device Name___________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Omnilux Revive and Blue Combination is intended to emit energy in the red and The Omnilux Revive and Blue Combination is michael to offically indicated to treat mild to moderate acne vulgaris.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR
Over The Counter Use _________________________________________________________________________________________________________________________________________________________
Signature
(Optional Format 1-2-96)
opiorative
043329