FDA.reportPublic FDA data

Picosecond Laser System

Primary DI
06970453270166
Brand
Picosecond Laser System
Company
Beijing ADSS Development Co., Ltd.
Model
PS10-B
Published
2022-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220268000Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.2022-08-23GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970453270166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970453270166069704532701666970453270166

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological frequency-doubled solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529128739
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970453270173Diode Laser Therapy MachineFG2000-B2025-10-30
06970453270180Diode Laser Therapy MachineFG2000-B pro2025-10-30
06970453270197Diode Laser Therapy MachineFG2000-D+ 2025-10-30
06970453270203Diode Laser Therapy MachineFG2000-D+pro 2025-10-30
06970453270210Diode Laser Therapy MachineFG2000-E2025-10-30
06970453270227Electromagnetic Stimulator DeviceEM Contouring2025-10-30
06970453270234Electromagnetic Stimulator DeviceTesla Duet2025-10-30
06970453270258Intensity Pulsed Light Therapy SystemVE20002025-10-30
06970453270265Intensity Pulsed Light Therapy SystemVE2000 Pro2025-10-30
06970453270272Intensity Pulsed Light Therapy SystemVE2000 Pro0012025-10-30
06970453270289Intensity Pulsed Light Therapy SystemVE2000 Pro0022025-10-30
06970453270296Intensity Pulsed Light Therapy SystemVE2000 PRO0032025-10-30
06970453270326Fractional CO2 Laser Therapy SystemFG900-S2025-10-30
06970453270333Fractional CO2 Laser Therapy SystemFG900-S22025-10-30
06970453270647Diode Laser Therapy MachineFG2000-D+ 2025-10-30
06970453270067Diode Laser Therapy MachineFG 20002022-08-30
06970453270074Diode Laser Therapy MachineFG 2000-B2022-08-30
06970453270081Diode Laser Therapy MachineFG 2000-C2022-08-30
06970453270098Diode Laser Therapy MachineFG 2000-D2022-08-30
06970453270159Picosecond Laser SystemPS10-A2022-10-31

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