(30 days)
The HOUVA 3 Phototherapy system with PhotoSense II™ Exposure Control is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.
Not Found
This FDA document is a 510(k) clearance letter for a phototherapy system. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trial data.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed scientific study demonstrating the device meets performance metrics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2004
Ms. Loretta Mooney Director of Regulatory Affairs National Biological Corporation 1532 Enterprise Parkway Twinsburg, Ohio 44087
Re: K041212
Trade/Device Name: HOUVA Phototherapy System with PhotoSense II™ Exposure Control Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorder Regulatory Class: II Product Code: FTC Dated: May 7, 2004 Received: May 11, 2004
Dear Ms. Mooney:
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. Loretta Mooney
This letter will allow you to begin marketing your device as described in your Section 510(k) This loter will acation. The FDA finding of substantial equivalence of your device to a legally premailer notification " 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 If you attent office of Compliance at (301) 594-4659. 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 from the Division of Small other general micronational 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,
Mark A. Milliken
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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National Biological Corporation
The Phototherapy Experts!
Attachment 3
Indications for Use
510(k) Number (if known): K041212
Device Name:
HOUVA 3 Phototherapy System with PhotoSense II™ Exposure Control
Indications for Use:
The HOUVA 3 Phototherapy system with PhotoSense II™ Exposure Control is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.
Prescription Usc (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 OF NEEDED)
Mark A. Mellone, CDRH, Office of Device Evaluation (ODE)
on-l Division of General, Restorative, and Neurological Devices
K0411212
510(k) Number
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.