AMER. MED. OPTICS ARGON/KRYPTON LASER

Laser, Ophthalmic

AMERICAN MEDICAL OPTICS

The following data is part of a premarket notification filed by American Medical Optics with the FDA for Amer. Med. Optics Argon/krypton Laser.

Pre-market Notification Details

Device IDK841856
510k NumberK841856
Device Name:AMER. MED. OPTICS ARGON/KRYPTON LASER
ClassificationLaser, Ophthalmic
Applicant AMERICAN MEDICAL OPTICS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-03
Decision Date1984-06-07

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