SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80

Powered Laser Surgical Instrument

SURGILASE, INC.

The following data is part of a premarket notification filed by Surgilase, Inc. with the FDA for Surgilase Co2 Surgical Laser System Model Sl80.

Pre-market Notification Details

Device IDK884092
510k NumberK884092
Device Name:SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80
ClassificationPowered Laser Surgical Instrument
Applicant SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick,  RI  02866
ContactTimothy J Shea
CorrespondentTimothy J Shea
SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick,  RI  02866
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-28
Decision Date1988-10-13

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