Picosecond Nd:YAG Laser Systems (Model: HS-298)

Shanghai Apolo Medical Technology 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

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3

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0

Device details

FDA 510(k) registration fields

K number
K260017
Device name
Picosecond Nd:YAG Laser Systems (Model: HS-298)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2026-01-05
Decision date
2026-04-09
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentVascular treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:
- Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Intended Use

The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. 532nm wavelength: - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Device Description

The Picosecond Nd: YAG Laser System (HS-298) is a Nd: YAG solid state laser, which can deliver the energy at picosecond pulse bursts to the skin. The system is composed of laser generator, articulated arm, handpiece, laser power supply, cooling system, display and control system. The Picosecond Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a Zoom handpiece, MLA hand piece, or DOE hand piece. The outputs of the two lasers are designed to be co linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064nm wavelengths.

Summary parsed at:2026-06-01 05:19:07 UTC

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