SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION

Powered Laser Surgical Instrument

SURGICAL LASER TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Contact Laser Systems For Photocoagulation.

Pre-market Notification Details

Device IDK895029
510k NumberK895029
Device Name:SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION
ClassificationPowered Laser Surgical Instrument
Applicant SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern,  PA  19355
ContactGifford, R.n.
CorrespondentGifford, R.n.
SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern,  PA  19355
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-08
Decision Date1989-10-16

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