Celalux 3
FDA 510(k) K153018 · Voco GmbH
510(k) numberK153018
Submission
- Device name
- Celalux 3
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- October 15, 2015
- Decision date
- June 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Celalux 3 cleared by the FDA?
Celalux 3 (K153018) received a 510(k) decision of Substantially Equivalent on June 23, 2016, 252 days after the submission was received.
What is the product code of K153018?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.