Devices

NANNOLIGHT INTENSE PULSED LIGHT SYSTEM

Model / Serial
Serial Numbers: 272102 280103 280104 280105 280901 281004 280810 280506 280509 280609 280808 280809 281304 280801 280206 280301 280306 280207 280402 280702 280703 280403 280405 280701 280701 280706 280210 280303 280805 280802 280108 280208 280302 280508 280604 280906 280908 280909 280910 281001 280804 280905 280209 280803 280409 280510 280610 280401 280709 280806 280708 280307 280807 280904 281005 280902 280304 280503 280507 and 281204. Serial numbers sumbitted 4/22/09.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
Sybaritic, Inc
1 Event
- Recall of NANNOLIGHT INTENSE PULSED LIGHT SYSTEM

Manufacturer

Sybaritic, Inc

Manufacturer Address
Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
Source
USFDA

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