CANDELA DYNAMIC COOLING DEVICE

Powered Laser Surgical Instrument

CANDELA CORP.

The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Dynamic Cooling Device.

Pre-market Notification Details

Device IDK001589
510k NumberK001589
Device Name:CANDELA DYNAMIC COOLING DEVICE
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactJoan M Clifford
CorrespondentJoan M Clifford
CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-23
Decision Date2000-08-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817495023601 K001589 000
00817495024004 K001589 000
00817495020587 K001589 000
00817495023649 K001589 000
00817495024882 K001589 000
00817495024905 K001589 000
00817495024943 K001589 000
00817495024967 K001589 000
00817495025001 K001589 000
00817495025025 K001589 000
00817495023632 K001589 000
00817495023618 K001589 000
00817495023625 K001589 000
00817495023670 K001589 000
00817495023984 K001589 000

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