FDA.reportPublic FDA data

PicoStar

Primary DI
04058784001078
Brand
PicoStar
Company
Asclepion Laser Technologies GmbH
Model
M16-9410-000
Device description
Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for tattoo removal and the treatment of benign pigmented lesions as well as wrinkles and acne scars.
Published
2022-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K213889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213889000PicoStarAsclepion Laser Technologies GmbH2022-04-22GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058784001078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058784001078040587840010784058784001078

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

Contacts#

Phone, Email table
PhoneEmail
+4936417700401service@asclepion.com
+493641770010info@asclepion.com

Regulatory Flags#

DUNS number
332247852
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058784002655MultiPulse TFLJ19-8000-000J19-8000-0002025-11-27
04058784002693MultiPulse TFLJ19-8100-000J19-8100-0002025-11-27
04058784001542OMNIO10-0200-0002025-08-08
04058784000132TattooStar16412018-06-04
04058784000026QuardoStar PRO14902016-09-17
04058784000033QuadroStar PRO14912016-09-17
04058784000057QuardoStar PRO14932016-09-17
04058784002037MultiCut Blade 350839-3200-0002024-11-22
04058784002044MultiCut Blade 400839-3300-0002024-11-22
04058784002617DermablateM18-4200-0002024-11-11
04058784002624DermablateM18-4300-0002024-11-11
04058784000279MeDioStarM10-0200-0002020-03-27
04058784001986MultiPulse HoPLUSJ19-1191-000J19-1191-0002024-06-25
04058784000996MultiPulse HoPLUSJ19-1151-000J19-1151-0002019-12-03
04058784001009MultiPulse HoPLUSJ19-1161-000J19-1161-0002019-12-02
04058784000224MCL 31 Dermablate18232018-01-30
04058784000071MeDioStar NeXT PRO15922016-11-14
04058784000095SmoothPulse PRO159222016-09-17
04058784000101Pronto159212016-09-17
04058784000293Bare Fiber 2.1 20029542019-03-01

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