Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.PicoSecond Nd: YAG Laser System
Shanghai Apolo Medical Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K200116
- Device name
- PicoSecond Nd: YAG Laser System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-01-21
- Decision date
- 2020-05-28
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment 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 for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 730 nm: • Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 785 nm: • Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The Resolve handpieces (532 nm HE, 532nm, 1064nm) are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV. The Resolve Fusion handpiece (532 nm) is indicated for the treatment of benign pigmented lesions in 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 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 handpiece. 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.
Summary parsed at:2026-06-01 05:47:43 UTC
Predicate devices
4—
—
Not ingested
PICOPLUS Laser System
—
—
Not ingested
PicoWay Laser System
K200116 references 4 predicate/reference devices
Cited as predicate
7Picocaremajesty
Picosecond Laser System (Model PS10-A and PS10-B)
Picosecond Nd:YAG Laser System
Medical Picosecond ND: YAG Laser System (PZ-6)
Picosecond Laser Device (PF131-BI)
Picosecond laser device (BMPS4)
Picosecond Nd:YAG Laser Systems (Model: HS-298)
7 submissions cite K200116 as a predicate
