Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
S2 Pigment Removal System is intended for use in removal of tattoo ink. The S2 Pigment Removal System is indicated for the removal of tattoo ink according to the following wavelengths: 800 nm: The LightSense S2 800 nm Ti:Sapphire laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-III. 532 nm: The LightSense S2 532 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-III. 1064 nm: The LightSense S2 1064 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-VI.
S2 Pigment Removal System is intended for use in removal of tattoo ink. The S2 Pigment Removal System is indicated for the removal of tattoo ink according to the following wavelengths: 800 nm: The LightSense S2 800 nm Ti:Sapphire laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-III. 532 nm: The LightSense S2 532 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I - III. 1064 nm: The LightSense S2 1064 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-VI.
The S2 Pigment Removal Laser System (S2) uses high intensity laser pulses to remove tattoo ink from skin. The S2 includes the two treatment lasers, an aiming beam, a small galvanometric scanner, an articulating arm, a hand-piece with an adjustable spacer, and a foot pedal. The S2 uses two lasers to deliver three working wavelengths: (1) 800nm, ultra-short pulsed Ti:Sapphire laser, and (2) 1064 and 532nm Nd:YAG short pulse laser. The combined lasers are designed to remove tattoos.
Summary parsed at:2026-06-01 05:41:51 UTC
PicoSure Workstation
K202848 references 1 predicate/reference device
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