510(k) K122997
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2013
- Date Received
- September 27, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photocoagulator And Accessories
- Device Class
- Class II
- Regulation Number
- 886.4690
- Review Panel
- OP
- Submission Type