Stellar M22
510(k) K250809
Stellar M22 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Lumenis Be Ltd, cleared under FDA 510(k) K250809 on 16 Apr 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 | NumberK250809 | Date16 Apr 2025 | StatusActive |
Official records
- FDA 510(k) database K250809
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Lumenis Be, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K250809
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Black Stellar XPL HP | NA | 07290117772645 | — | On the market |
| M22™ Q-Switched Head | NA | 07290117772744 | — | On the market |
| Multi-Spot™ Nd:YAG Head | NA | 07290117772737 | — | On the market |
| Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kit | NA | 07290117772751 | — | On the market |
| Stellar M22™ Q-Switched Nd:YAG Upgrade Kit | NA | 07290117772768 | — | On the market |
| Stellar XPL Module Kit | NA | 07290117772652 | — | On the market |
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Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
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