Manufacturer
Focus Medical, LLCNaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
Country / Region:United States (US)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
- K151473
- Device name
- NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
- Company
- Focus Medical, LLC
- 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
Predicate devices
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Cited as predicate
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