510(k) K072823
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2007
- Date Received
- October 2, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type