Manufacturer
Lightsense Technologies, Ltd.S2 Pigment Removal System
Country / Region:United Kingdom (GB)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K202848
- Device name
- S2 Pigment Removal System
- Country / Region
- United Kingdom(GB)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-09-25
- Decision date
- 2021-12-14
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
1PicoSure Workstation
K202848 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K202848 as a predicate
