LUCEA LED SURGICAL LIGHT SYSTEM

Led Light Source

MAQUET SAS

The following data is part of a premarket notification filed by Maquet Sas with the FDA for Lucea Led Surgical Light System.

Pre-market Notification Details

• Device ID: K113679
• 510k Number: K113679
• Device Name: LUCEA LED SURGICAL LIGHT SYSTEM
• Classification: Led Light Source
• Applicant: MAQUET SAS 45 BARBOUR POND DRIVE Wayne, NJ 07470
• Contact: Whitney Torning
• Correspondent: Whitney Torning; MAQUET SAS 45 BARBOUR POND DRIVE Wayne, NJ 07470
• Product Code: NTN
• Subsequent Product Code: FSS
• Subsequent Product Code: FTD
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-12-14
• Decision Date: 2012-01-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700712404710	K113679	000
03700712401122	K113679	000
03700712401115	K113679	000
03700712400781	K113679	000
03700712400774	K113679	000
03700712400767	K113679	000
03700712400750	K113679	000
03700712400705	K113679	000
03700712400699	K113679	000
03700712400682	K113679	000
03700712400675	K113679	000
03700712400668	K113679	000
03700712400651	K113679	000
03700712400644	K113679	000
03700712400637	K113679	000
03700712400620	K113679	000
03700712401139	K113679	000
03700712401146	K113679	000
03700712401153	K113679	000
03700712400743	K113679	000
03700712400736	K113679	000
03700712400729	K113679	000
03700712400712	K113679	000
03700712404741	K113679	000
03700712404734	K113679	000
03700712404727	K113679	000
03700712404703	K113679	000
03700712404697	K113679	000
03700712404680	K113679	000
03700712404673	K113679	000
03700712404666	K113679	000
03700712401184	K113679	000
03700712401177	K113679	000
03700712401160	K113679	000
03700712400613	K113679	000