TitanPico Laser Workstation (PICO-450)

Rhein Laser Technologies Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K233757
Device name
TitanPico Laser Workstation (PICO-450)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-11-24
Decision date
2024-04-11
Submission type
Traditional
Technology type
Picosecond(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The TitanPico Laser Workstation is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

Intended Use

The TitanPico Laser Workstation is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

Device Description

TitanPico Laser Workstation is a laser system that delivers energy in the 532nm and 1064nm wavelength. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.

Summary parsed at:2026-06-01 05:27:03 UTC

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