DEVICE: TattooStar Effect COMBO (04058784000064)

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Device Identifier (DI) Information

TattooStar Effect COMBO
1680

Asclepion Laser Technologies GmbH
04058784000064
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dermatological frequency-doubled solid-state laser system A 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.
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FDA Product Code

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Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 14, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+4936417700401
service@asclepion.com
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