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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Dermablate - 04058784002624

Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
M18-4300-000
In Commercial Distribution

  • 04058784002624 ()


  • Multi-modality skin surface treatment system generator

Dermablate - 04058784002617

Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
M18-4200-000
In Commercial Distribution

  • 04058784002617 ()


  • Multi-modality skin surface treatment system generator

MCL 31 Dermablate - 04058784000224

Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
1823
In Commercial Distribution

  • 04058784000224 ()


  • Multi-modality skin surface treatment system generator

MCL 31 Dermablate - 04058784000088

Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
1821
In Commercial Distribution

  • 04058784000088 ()


  • Multi-modality skin surface treatment system generator

ICON CONTROL MODULE REMAN - 00841494103774

ICON CONTROL MODULE REMAN
Cynosure, LLC
2520-0003R
In Commercial Distribution

  • 00841494103774 ()


  • Multi-modality skin surface treatment system generator

ASSY, 1540 HANDPIECE, ICON - 00841494100520

ASSY, 1540 HANDPIECE, ICON
Cynosure, LLC
2520D-1540
In Commercial Distribution

  • 00841494100520 ()


  • Multi-modality skin surface treatment system generator

1540 HANDPIECE ICON, REMANUFACTURED - 00841494102272

1540 HANDPIECE ICON, REMANUFACTURED
Cynosure, LLC
2520D-1540R
In Commercial Distribution

  • 00841494102272 ()


  • Multi-modality skin surface treatment system generator

Refurbished Applicator Frax 1550 - 00817495025070

Refurbished Applicator Frax 1550
Candela Corporation
FIN101208
In Commercial Distribution

  • 00817495025070 ()


  • Multi-modality skin surface treatment system generator

Nordlys Mini - 00817495023960

Nordlys Mini Laser System
Candela Corporation
9SYS7853
In Commercial Distribution

  • 00817495023960 ()


  • Multi-modality skin surface treatment system generator

1550 Applicator - 00817495023953

1550 Applicator (1550 nm) for Nordlys and Nordlys Mini
Candela Corporation
9APP7830
In Commercial Distribution

  • 00817495023953 ()


  • Multi-modality skin surface treatment system generator
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