510(k) K881494

FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER by Biophysic Medical, Inc. — Product Code HQF

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