Lumenis Stellar M22
FDA 510(k) clearance DEN200028 · decided 2021-02-23
Clearance details
- K-number
- DEN200028
- Device name
- Lumenis Stellar M22
- Applicant
- Lumenis, Ltd.
- Decision
- Unknown
- Date received
- 2020-04-20
- Decision date
- 2021-02-23
- Days to decision
- 309 days
- Clearance type
- Direct
- Product code
- QIU
- Device class
- 2
- Regulation number
- 886.5201
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.