PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.

Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

PHOENIX LASER SYSTEMS, INC.

The following data is part of a premarket notification filed by Phoenix Laser Systems, Inc. with the FDA for Phoenix Laser Systems Ophthalmic Surgical Worksta..

Pre-market Notification Details

Device IDK901605
510k NumberK901605
Device Name:PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
ClassificationLaser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Applicant PHOENIX LASER SYSTEMS, INC. 205 25TH AVENUE NORTH St. Petersburg,  FL  33704
ContactJoann R Schulz
CorrespondentJoann R Schulz
PHOENIX LASER SYSTEMS, INC. 205 25TH AVENUE NORTH St. Petersburg,  FL  33704
Product CodeLXS  
CFR Regulation Number886.4392 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-05
Decision Date1990-12-13

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