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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.

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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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