510(k) K801336
K801336 is an FDA 510(k) premarket notification submitted by Coherent Medical Division for the device "MODEL 900K PHOTOCOAGULATOR". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Coherent Medical Division has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1980
- Date Received
- June 4, 1980
- 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