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Lumenis, Inc.

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 recall (Z-0194-2022)Lumenis, Inc.2021-11-04
Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessor recall (Z-2733-2014)Lumenis, Inc.2014-09-30
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use recall (Z-2191-2013)Lumenis, Inc.2013-09-11
Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO recall (Z-2652-2010)Lumenis, Inc.2010-09-30
Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, recall (Z-0585-2008)Lumenis, Inc.2008-04-09
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft recall (Z-0028-2007)Lumenis Inc.2006-10-12
Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before N recall (Z-0545-06)Lumenis Inc.2006-03-02
Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured recall (Z-0556-06)Lumenis Inc.2006-02-23
Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Man recall (Z-0529-06)Lumenis Inc.2006-02-16

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Every clearance here is in the API, with alerts when new ones post.