COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE

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 Coherent Versapulse(tm) 2.1xe/2.1l Holmi Surg Lase.

Pre-market Notification Details

Device IDK914136
510k NumberK914136
Device Name:COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE
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 (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-16
Decision Date1992-07-21

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