FDA.reportPublic FDA data

TattooStar Effect COMBO

Primary DI
04058784000064
Brand
TattooStar Effect COMBO
Company
Asclepion Laser Technologies GmbH
Model
1680
Device description
Dermatological laser with the wavelengths 1064 nm, 532 nm, 585 nm and 694 nm. Intended for the removal of tattoos, pigmented lesions, vascular lesions and skin resurfacing.
Published
2016-11-14
Public version status
Update
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
K131757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131757000TATTOOSTAR EFFECT COMBOAsclepion Laser Technologies GmbH2014-07-17GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058784000064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058784000064040587840000644058784000064

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 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

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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