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Terminated

Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included); 2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform configuration; 4.) 404207-B Completed unit, matte finish, 220 Volt; 5.) 404207-USAB Completed unit, matte finish, 220 Volt, USA-style power cord; 6.) 404208-B Completed unit, matte finish, 110 Volt; and 7.) 404208-MP Completed unit, matte finish, 110 Volt, Multi-Platform configuration. The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

FDA Recall Z-1444-2009 · Posted 2009-09-03

Recalling FirmSybaritic, Inc
Recall StatusTerminated
Product CodeGEX
Date Initiated2008-04-12
Date Terminated2012-07-05
Product Quantity59

Reason for Recall

Sybaritic Inc. had an issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments.

Firm Action

A "Sybaritic" notification letter dated April 15, 2008 was issued to consignees. The letter described the modifications to the protocols for the NannoLight MP50 and the temporary replacement of 585 Filter for the 560 Filter for Vascular Lesions until further notice. They requested the immediate use of the protocols replacing all other versions. A follow-up letter dated June 3, 2008 was issued to customers. The letter included an attachment " Product Notice Nannolight MP50 585 nm "special" filter from Sybaritic, Inc. The letter described the new 585 nm "bandwidth filter". Also the notification advised consignees to discontinue the use of the old 585 filter and to use 560nm filter until they receive the new 585 nm bandwidth filter. Please direct any questions to your Account Manager or to Sybaritic, Inc. by calling 1-800-445-8418 or 1-952-888-8282.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- US (states of WA, CA, MN, FL and AR), POLAND, THAILAND, CHILE, CANADA, KOREA, AZERBAIJAN, INDIA, SPAIN, ARGENTINA, RUSSIA, GREECE, PHILIPPINES, POLAND, INDIA, JORDAN, TURKEY, MEXICO, URUGUAY,BELGIUM, LEBANON, BULGARIA and SINGAPORE.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082033NANNOLIGHT INTENSE PULSED LIGHT SYSTEMGlobal USA Distribution, LLC · 2008-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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