510(k) K833274
K833274 is an FDA 510(k) premarket notification submitted by Synemed, Inc. for the device "DERMATOLOGY HANDPIECE-OPHTH LASER". The FDA issued a decision of Substantially Equivalent on December 3, 1983. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Synemed, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1983
- Date Received
- September 21, 1983
- 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