Bluemoon
510(k) K242386
Bluemoon is a Class II device made by GENOSS CO., Ltd., cleared under FDA 510(k) K242386 on 5 May 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242386 | Date5 May 2025 | StatusActive |
Official records
- FDA 510(k) database K242386
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBZ
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6070
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code EBZ (Activator, Ultraviolet, For Polymerization).
- BLUELEX by Monitex Industrial Co., Ltd.
- VALO 5923-D by ULTRADENT PRODUCTS, INC.
- ASTRALIS 7, MODEL 557545 by Ivoclar Vivadent, Inc.
- ASTRALIS 10, MODELS # 559588, 561859 by Ivoclar Vivadent, Inc.
- TRANSLUX POWER BLUE by Heraeus Kulzer, Inc.
- SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE by Satelec - Acteon Group
- LED TURBO by APOZA ENTERPRISE CO., LTD.
- VALO 5971 by ULTRADENT PRODUCTS, INC.
- NOVA-PULSE by Nova Ranger, Inc.
- G-LIGHT by Gc America Inc.