(178 days)
To provide topical heating for the temporary rellef of minor muscle and foint pains and stiffness,
the temporary relief of minor joint pain assoclated with arthritls,
the temporary Increase In local blood clrculation where applied,
the relaxation of muscles, and
help muscle spasms, minor sprains and strains, and minor muscular back paln.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Cold Light; Cold Light MD; and Gossamer Dermlight." This type of letter addresses the substantial equivalence of a new device to a predicate device, based on its indications for use and general safety/effectiveness considerations, rather than detailed performance study results against specific acceptance criteria.
Therefore, the provided document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about the training set used for a performance study.
The document primarily focuses on:
- Device Name: Cold Light, Cold Light MD, and Gossamer Dermlight
- Indications for Use: To provide topical heating for temporary relief of minor muscle and joint pains and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local blood circulation, muscle relaxation, and help with muscle spasms, minor sprains/strains, and minor muscular back pain.
- Regulatory Classification: Class II, Product Code ILY, Regulation Number 21 CFR 890.5500 (Infrared lamp).
- Predicate Device: Not explicitly named, but the clearance implies a comparison to a legally marketed predicate.
- Over-The-Counter (OTC) Use: Corrected from an earlier letter that stated Prescription Use.
To answer your request, a different type of document, such as a study report or clinical trial summary, would be needed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2005
Mr. Roger Machson President Onyx Medical, Inc. 445 Coloma Street Sausalito, California 94965
Re: K041679
Trade/Device Name: Cold Light; Cold Light MD; and Gossamer Dermlight Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 26, 2004 Received: October 28, 2004
Dear Mr. Machson:
This letter corrects our substantially equivalent letter of December 16, 2004 regarding the Indications for Use page. The device should be OTC, not Prescription.
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 - Mr. Roger Machson
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 (240) 276-0115. 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 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,
Muriam C. 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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Indications for Use
510(k) Number: K041679
Cold Light; Cold Light MD; and Gossamer Dermlight Device Name(s):
Indications For Use:
The Cold Light, Cold Light MD, and Gossamer DermLight are indicated for use as follows:
To provide topical heating for the temporary rellef of minor muscle and foint pains and stiffness,
the temporary relief of minor joint pain assoclated with arthritls,
the temporary Increase In local blood clrculation where applied,
the relaxation of muscles, and
help muscle spasms, minor sprains and strains, and minor muscular back paln.
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)
Page 1 of _
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
RO41619 510(k) Number
N/A