510(k) K782065
K782065 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "LASER, PHOTOCOAGULATION". The FDA issued a decision of Substantially Equivalent on December 28, 1978. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Cavitron Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1978
- Date Received
- December 13, 1978
- 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