SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER

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 Superpulse Ambulase (xam-sp) Co2 Surgical Laser.

Pre-market Notification Details

Device IDK873760
510k NumberK873760
Device Name:SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER
ClassificationPowered Laser Surgical Instrument
Applicant COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto,  CA  94303
ContactVirginia Singer
CorrespondentVirginia Singer
COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto,  CA  94303
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-16
Decision Date1987-11-27

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