510(k) K253004
K253004 is an FDA 510(k) premarket notification submitted by Lap GmbH Laser Applikationen for the device "LUNA 3D". The FDA issued a decision of Substantially Equivalent on June 4, 2026. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Lap GmbH Laser Applikationen has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2026
- Date Received
- September 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type