NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module

Focus Medical, LLC

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

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Device details

FDA 510(k) registration fields

K number
K151473
Device name
NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-06-01
Decision date
2015-09-01
Submission type
Traditional
Technology type
Q-Switched(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

NaturaLase PiQo4 – The NaturaLase Nd:YAG 1064 Q-switched Laser with 532 KTP Optics and Pulse Slicing Module – is indicated for use in aesthetic applications at the specified wavelength: 532 nm – removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 1064 nm – Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat tattoo colors: black, brown, green, blue and purple.

Intended Use

NaturaLase PiQo4 – The NaturaLase Nd:YAG 1064 Q-switched Laser with 532 KTP Optics and Pulse Slicing Module – is indicated for use in aesthetic applications at the specified wavelength: 532 nm – removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 1064 nm – Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat tattoo colors: black, brown, green, blue and purple.

Device Description

The NaturaLase PiQo4 laser is a Nd:YAG 1064 Q-Switched laser with 532 KTP Optics and Pulse Slicing Module. The 532 KTP Optics is available to convert the basic 1064 nm wavelength to 532 nm and the pulse slicing electro-optics allows diverting the leading and trailing portions of the laser pulse away from the delivery system for the purpose of shortening the pulse duration without reducing the peak power. The NaturaLase PiQo4 laser offers fast and efficient treatment of tattoos and benign pigmented lesions removal through a variety of spot sizes, fluences and repetition rates. The laser energy is delivered via an articulated arm with interchangeable hand-pieces. A liquid crystal display (LCD) provides visual feedback of control settings and operating parameters. The mechanism of action for tattoo or pigmented lesion removal lies in delivering laser energy at very high peak power.

Summary parsed at:2026-06-01 06:11:16 UTC

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