SPECTRA HAIR REMOVAL LASER

Powered Laser Surgical Instrument

SPECTRAGENICS, INC.

The following data is part of a premarket notification filed by Spectragenics, Inc. with the FDA for Spectra Hair Removal Laser.

Pre-market Notification Details

Device IDK052848
510k NumberK052848
Device Name:SPECTRA HAIR REMOVAL LASER
ClassificationPowered Laser Surgical Instrument
Applicant SPECTRAGENICS, INC. 5880 WEST LAS POSITAS BLVD. SUITE 52 Pleasanton,  CA  94588
ContactRobert E Grove
CorrespondentRobert E Grove
SPECTRAGENICS, INC. 5880 WEST LAS POSITAS BLVD. SUITE 52 Pleasanton,  CA  94588
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-07
Decision Date2005-12-27
Summary:summary

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