K231011
- 510(k) number
- K231011
- Device name
- Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
- Applicant
- Meridian AG CH
- Product code
- HQF — Laser, Ophthalmic
- Decision date
- 2023-09-12
- Date received
- 2023-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231011
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.