← Back to catalogue

Picosecond Laser System (Model PS10-A and PS10-B)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220268

by Beijing ADSS Development Co., Ltd.

Identifiers

510(k) Number
K220268 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Picosecond Laser System (Models PS10-A and PS10-B) is a medical device classified as a Picosecond Laser (Product Code GEX) under the FDA’s General, Plastic Surgery category. It delivers ultra-short laser pulses measured in picoseconds to target and fragment pigmented lesions, including benign pigmented lesions on Fitzpatrick skin types I-IV, and human blue-black tattoos through photothermolysis.

This system is intended for use in medical dermatology and plastic surgery settings. Supplied as a reusable medical device, it requires proper sterilization and maintenance per manufacturer guidelines. The device has received FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Regulation (MDR). No specific MRI safety classification is stated in the available data.

Frequently asked questions

What types of skin conditions or tattoos can the Picosecond Laser System treat, and what skin tones are suitable for use with this device?

The Picosecond Laser System (Models PS10-A and PS10-B) is designed to treat pigmented lesions, including benign pigmented lesions, and human blue-black tattoos. It is specifically approved for use on Fitzpatrick skin types I-IV, which cover a range of lighter to moderate skin tones. The device works by delivering ultra-short laser pulses to fragment pigment through photothermolysis, making it suitable for these conditions and skin types.

Is the Picosecond Laser System reusable, and if so, what sterilization and maintenance procedures should be followed?

Yes, the Picosecond Laser System is supplied as a reusable medical device. To ensure safety and functionality, it must be sterilized and maintained according to the manufacturer’s guidelines. Proper sterilization is critical to prevent contamination and ensure reliable performance during use in dermatology and plastic surgery settings.

Are there different models of the Picosecond Laser System, and if so, how do they differ?

The Picosecond Laser System comes in two models: PS10-A and PS10-B. While the exact differences between the models are not detailed in the provided data, both are classified under the same product code (GEX) and intended for the same clinical applications—targeting pigmented lesions and tattoos. The models may vary in technical specifications or features, but their core purpose remains consistent.

What regulatory pathways has the Picosecond Laser System followed, and what does this mean for its use in clinical settings?

The Picosecond Laser System has received FDA 510(k) clearance under the Traditional pathway, meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. Additionally, it complies with the Medical Device Regulation (MDR). This regulatory clearance indicates that the device meets the necessary safety and effectiveness standards for use in medical dermatology and plastic surgery settings, as intended by the manufacturer.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Picosecond Laser System (Model PS10-A and PS10-B) (K220268) — FDA 510 ..., Picosecond - Wikipedia, Picosecond Laser System - Beijing ADSS Development Co.,Ltd, Picosecond Laser System (Model PS10-A And PS10-B)… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Beijing ADSS Development Co., Ltd.

Sources (2)

  • FDA 510(k) K220268 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026