G-Light
FDA 510(k) K050059 · GC America, Inc.
510(k) numberK050059
Submission
- Device name
- G-Light
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- January 11, 2005
- Decision date
- February 3, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was G-Light cleared by the FDA?
G-Light (K050059) received a 510(k) decision of Substantially Equivalent on February 3, 2005, 23 days after the submission was received.
What is the product code of K050059?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.