CANDELA GENTLELASE FAMILY OF LASER SYSTEMS

Powered Laser Surgical Instrument

CANDELA CORP.

The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Gentlelase Family Of Laser Systems.

Pre-market Notification Details

• Device ID: K140732
• 510k Number: K140732
• Device Name: CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
• Classification: Powered Laser Surgical Instrument
• Applicant: CANDELA CORP. 530 BOSTON POST ROAD Wayland, MA 01778
• Contact: Sam Wade
• Correspondent: Sam Wade; CANDELA CORP. 530 BOSTON POST ROAD Wayland, MA 01778
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-24
• Decision Date: 2014-11-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817495020754	K140732	000
00817495020884	K140732	000
00817495020877	K140732	000
00817495022093	K140732	000
00817495022086	K140732	000
00817495022079	K140732	000
00817495022703	K140732	000
00817495022550	K140732	000
00817495022543	K140732	000
00817495022529	K140732	000
00817495022505	K140732	000
00817495022499	K140732	000
00817495022482	K140732	000
00817495022475	K140732	000
00817495022468	K140732	000
00817495020921	K140732	000
00817495020938	K140732	000
00817495020945	K140732	000
00817495020747	K140732	000
00817495020730	K140732	000
00817495020723	K140732	000
00817495020716	K140732	000
00817495020709	K140732	000
00817495020693	K140732	000
00817495020686	K140732	000
00817495020679	K140732	000
00817495020662	K140732	000
00817495020372	K140732	000
00817495020334	K140732	000
00817495021003	K140732	000
00817495020990	K140732	000
00817495020983	K140732	000
00817495022451	K140732	000
00817495022444	K140732	000
00817495021836	K140732	000
00817495021539	K140732	000
00817495022024	K140732	000
00817495021829	K140732	000
00817495021812	K140732	000
00817495021805	K140732	000
00817495020068	K140732	000
00817495025193	K140732	000
00817495025179	K140732	000
00817495025162	K140732	000
00817495025148	K140732	000
00817495024332	K140732	000
00817495023908	K140732	000
00817495024646	K140732	000
00817495021843	K140732	000
00817495021850	K140732	000
00817495021867	K140732	000
00817495022390	K140732	000
00817495022383	K140732	000
00817495022369	K140732	000
00817495022291	K140732	000
00817495022062	K140732	000
00817495022031	K140732	000
00817495022000	K140732	000
00817495021973	K140732	000
00817495021966	K140732	000
00817495021959	K140732	000
00817495021942	K140732	000
00817495021935	K140732	000
00817495021928	K140732	000
00817495021904	K140732	000
00817495023557	K140732	000
00817495020761	K140732	000
08174950202707	K140732	000
08174950200949	K140732	000
08174950200932	K140732	000
08174950200925	K140732	000
08174950200888	K140732	000
08174950200871	K140732	000
08174950200802	K140732	000
08174950200796	K140732	000
08174950200789	K140732	000
08174950200772	K140732	000
08174950200765	K140732	000
08174950200758	K140732	000
08174950200741	K140732	000
08174950200734	K140732	000
08174950200727	K140732	000
08174950200987	K140732	000
08174950200994	K140732	000
08174950201007	K140732	000
08174950202554	K140732	000
08174950202547	K140732	000
08174950202523	K140732	000
08174950202509	K140732	000
08174950202493	K140732	000
08174950202486	K140732	000
08174950202479	K140732	000
08174950202462	K140732	000
08174950202455	K140732	000
08174950202448	K140732	000
08174950202028	K140732	000
08174950201823	K140732	000
08174950201816	K140732	000
08174950201809	K140732	000
08174950200710	K140732	000
08174950200703	K140732	000
00817495020242	K140732	000
00817495020235	K140732	000
00817495020228	K140732	000
00817495020211	K140732	000
00817495020198	K140732	000
00817495020181	K140732	000
00817495020129	K140732	000
00817495020105	K140732	000
00817495020099	K140732	000
00817495020082	K140732	000
00817495020075	K140732	000
00817495020808	K140732	000
00817495020792	K140732	000
00817495020785	K140732	000
08174950200062	K140732	000
08174950200079	K140732	000
08174950200086	K140732	000
08174950200697	K140732	000
08174950200680	K140732	000
08174950200673	K140732	000
08174950200376	K140732	000
08174950200338	K140732	000
08174950200246	K140732	000
08174950200239	K140732	000
08174950200222	K140732	000
08174950200215	K140732	000
08174950200192	K140732	000
08174950200185	K140732	000
08174950200123	K140732	000
08174950200109	K140732	000
08174950200093	K140732	000
00817495020778	K140732	000