Optilux 501
FDA 510(k) K020091 · Kerr Corporation (Danbury)
510(k) numberK020091
Submission
- Device name
- Optilux 501
- Applicant
- Kerr Corporation (Danbury)
Orange, CA, US - Received
- January 10, 2002
- Decision date
- March 21, 2002
- 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 501 cleared by the FDA?
Optilux 501 (K020091) received a 510(k) decision of Substantially Equivalent on March 21, 2002, 70 days after the submission was received.
What is the product code of K020091?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.