MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE

Powered Laser Surgical Instrument

COHERENT MEDICAL GROUP

The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Model 920 Argon/dye Laser-for Dermatological/use.

Pre-market Notification Details

Device IDK852860
510k NumberK852860
Device Name:MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE
ClassificationPowered Laser Surgical Instrument
Applicant COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto,  CA  94303
ContactLen Goldfine
CorrespondentLen Goldfine
COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto,  CA  94303
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-08
Decision Date1985-10-07

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