Cold Light; Cold Light MD; Gossamer Dermlight
FDA 510(k) K041679 · Onyx Medical, Inc.
510(k) numberK041679
Submission
- Device name
- Cold Light; Cold Light MD; Gossamer Dermlight
- Applicant
- Onyx Medical, Inc.
Sausalito, CA, US - Received
- June 21, 2004
- Decision date
- December 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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| K934615 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
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Questions and answers
When was Cold Light; Cold Light MD; Gossamer Dermlight cleared by the FDA?
Cold Light; Cold Light MD; Gossamer Dermlight (K041679) received a 510(k) decision of Substantially Equivalent on December 16, 2004, 178 days after the submission was received.
What is the product code of K041679?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.