510(k) K881494
K881494 is an FDA 510(k) premarket notification submitted by Biophysic Medical, Inc. for the device "FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER". The FDA issued a decision of SN on August 30, 1988. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Biophysic Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- August 30, 1988
- Date Received
- April 8, 1988
- 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