510(k) K841855

AMER. MED. OPTICS ARGON LASER PHOTO by American Medical Optics — Product Code HQF

K841855 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMER. MED. OPTICS ARGON LASER PHOTO". The FDA issued a decision of Substantially Equivalent on June 19, 1984. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. American Medical Optics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
May 3, 1984
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