Optilux 400
FDA 510(k) K955763 · Demetron Research Corp.
510(k) numberK955763
Submission
- Device name
- Optilux 400
- Applicant
- Demetron Research Corp.
Glendora, CA, US - Received
- December 20, 1995
- Decision date
- January 4, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Optilux 400 cleared by the FDA?
Optilux 400 (K955763) received a 510(k) decision of Substantially Equivalent on January 4, 1996, 15 days after the submission was received.
What is the product code of K955763?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.