K242397
- 510(k) number
- K242397
- Device name
- LYNX Photocoagulator
- Applicant
- Norlase Aps DK
- Product code
- HQF — Laser, Ophthalmic
- Decision date
- 2024-10-25
- Date received
- 2024-08-13
- 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: K242397
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.