AP01 AND AP02

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 Ap01 And Ap02.

Pre-market Notification Details

Device IDK925908
510k NumberK925908
Device Name:AP01 AND AP02
ClassificationPowered Laser Surgical Instrument
Applicant SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks,  PA  19456 -0880
ContactTerry A Fuller
CorrespondentTerry A Fuller
SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks,  PA  19456 -0880
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-20
Decision Date1993-07-02

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