(103 days)
The Omnilux Plus is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and temporarily increase local blood circulation where applied.
The Omnilux Plus is a near infra-red light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output wavelength is 830 ± 5 nm. The Omnilux Plus 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 user interface 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 document is a 510(k) Summary for the Omnilux Plus device, which is an infrared lamp. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices and detailing the general information and indications for use.
Therefore, I cannot provide the requested information based on the given text. The document states "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Photo Therapeutics Limited believes that no anges of safety or effectiveness." This statement, however, is a general assertion rather than a description of an actual study with acceptance criteria and results.
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Kc43317 1 of 2
MAR 1 5 2005 510(k) Summary of Safety and Effectiveness for the K/ Suinthan Sentics Limited Omnilux Plus
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with This STO(K) Summary of Baroy and 21 CFR 807.92.
1. General Information
| Submitter: | Photo Therapeutics LimitedStation HouseStamford New RoadAltrinchamCheshire WA14 1EPUnited Kingdom |
|---|---|
| Contact Person: | Steve HutsonDirector of Engineering and RegulatoryAffairsPhoto Therapeutics LimitedStation HouseStamford New RoadAltrinchamCheshire WA14 1EPUnited Kingdom |
| Summary Preparation Date: | November 26th, 2004 |
| Device Name: | Omnilux Plus |
| Classification Name: | Lamp, InfraredProduct Code: ILYPanel: 89 |
3. Predicate Devices
The Omnilux Plus is substantially equivalent to the following device:
Photonic Stimulator manufactured by Bales Scientific Inc (K974468) I notome Buildian Warp 10 manufactured by Quantum Devices Inc (K032229) Quantum Warp Tourp Torce Therapy Inc (K022888) Pain-X-2000 manufactured by DioMedics Inc (K0982546) I am-X 2006 manufactured by Bioscan Inc (K993684 & 5)
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4. Device Description
The Omnilux Plus is a near infra-red light source of high spectral purity. It
in the course of the county of for cillumination. The output is pre-tuned to The Omnilux Plus is a near intra-ted illumination. The output is pre-tuned to one
provides uniform or "hot-spot" free illumination. The output wavelength is 830 ± 3 provides uniform or "hot-spor" free intention." The output wavelength is 830 ± 5
wavelength with a narrow spectral bandwidth. The output wavelength is 830 ± 5 wavelength with a narrow spectral banking the power supplies and the control unit.
nm. The Omnilux Plus base unit contains the power supplies and the attached nm. The Omnilux Plus base unit contains are power JED head can be attached
Attached to the base unit are three folding arms. The control uni Attached to the base unit are three for patient treatment. The control unit
to the end of the arms and then positioned for patient treatments. The user to the end of the arms and then position with the control electronics. The user
consists of an LCD and keyboard ogether with the control all device functions. consists of an I.C.D and keyboard together with the centrel all device functions.
interface software allows the operator to access and control all device functions.
5. Indications for Use
The Omnilux Plus is intended to emit energy in the IR spectrum to provide topical The Omnilux Plus is intended to cimi circle to the temperature; for the temporary relief
heating for the purpose of elevating tissue to collegam; relieving stiffeess heating for the purpose of elevaling tissue tony scile spasm; relieving stiffiness;
of minor muscle and joint pain, arthritis and museur ly increase local ble of minor muscle and Joint pain, attifitis and massis open >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> circulation where applied.
6. Performance Data
Based upon an analysis of the overall performance characteristics for the device, Based upon an affalysis of the overall person significant differences exist.
Photo Therapeutics Limited believes that no significant offectivene Photo Therapeutics Limited believes that he ages of safety or effectiveness.
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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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three wavy lines that resemble a stylized representation of a staff with snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 15 2005
Mr. Steve Hutson Mr. Blove Hangineering and Regulatory Affairs Photo Therapeutics Limited Station House Stamford New Road Altrincham Cheshire WA14 1EP
Re: K043317
Trade/Device Name: Omnilux Plus Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 7, 2005 Received: February 16, 2005
Dear Mr. Hutson:
We have reviewed your Section 510(k) premarket notification of intent to market the devices in We have reviewed your Section 910(tr) premained instantially equivalent (for the indications referenced above and have uctchined the de rood on the devices marketed in interstate for use stated in the encrosale) to regally manetee provide of the Medical Device American Food Drug commerce prior to May 28, 1776, the enaement and the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMAN devices that have been recure approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approvince of controls provisions of the Act. The You may, merelote, market the devices, bac, or annual registration, listing of general controls provisions of the Herman of and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it ( If your device is classified (see above) mto entrel on a consisted in the climit on EDA may may be subject to such additional controlise "Litter Stage of Soloto 898. In addition, FDA may be found in the Code of Peachar Regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issuated or a saconcies with other requirements of the Act that FDA has made a decemmation that Journer Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act 31equirements (01); good manufacturing practice requirements as set CFK Part 807), tabening (21 C.F.C.T.C. (201), gold time (20); and If applicable, the electronic (200), 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Steve Hutson
This letter will allow you to begin marketing your device as described in your Section 510(k)
the same of the first of the same of the same of wour device to a legal This letter will anow you to begin hankeling of substantial equivalence of your device to a legally premarket notification. The PDA midning of successification 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
r the regulation of the 01-07-2115 - Alamate the ragulation entilled if you desire specific advice for your do not to a saat note the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the may obtain contact the Office of Comphance at (210) 275 art 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 800 Overies of Small "Misbranding by reference to premarket nothreation of Set from the Division of Small
other general information on your responsibilities under the Act from the (800) 638, 04 other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Prisistance workedrinindustry/support/index.html.
Sincerely yours,
E. G. Anker
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
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Indications for Use
510(k) Number (if known): K043317
Device Name __________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Omnilux Plus is used for the temporary relief of minor muscle and joint pain, The Onlinds I rus is assurer are the capper the relaxation of muscle atunitis and musers spirations of all blood circulation where applied.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over The Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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El. Thm
(Division Sign-Off) Division of Ger. . and Neurological Devices
.(k) Number K043317
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.