Bluemoon
FDA 510(k) K242386 · Genoss Co., Ltd.
510(k) numberK242386
Submission
- Device name
- Bluemoon
- Applicant
- Genoss Co., Ltd.
Suwon-Si, CN - Received
- August 12, 2024
- Decision date
- May 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Bluemoon cleared by the FDA?
Bluemoon (K242386) received a 510(k) decision of Substantially Equivalent on May 5, 2025, 266 days after the submission was received.
What is the product code of K242386?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.