AccessGUDID - DEVICE: MCL 31 Dermablate (04058784000088)

GUDID

Device Identifier (DI) Information

Brand Name: MCL 31 Dermablate
Version or Model: 1821
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Asclepion Laser Technologies GmbH

Primary DI Number: 04058784000088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332247852 *Terms of Use

Device Description: Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45223	Multi-modality skin surface treatment system generator	A mains electricity (AC-powered) mobile (on wheels) device that combines technologies and may include an intense pulsed light (IPL) or IPL with radio-frequency (RF) generator, fluorescent light generator, pulsed ultraviolet B (UVB) light generator, Er:YAG lasers, Er:Glass lasers, long-pulsed Nd:YAG lasers, and Q-switched Nd:YAG lasers, as part of a multi-modality skin surface treatment system intended to be used for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). Dedicated applicators are used to apply the different energies to the skin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150140	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab2cdd55-a957-4416-9809-65e736897383
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 14, 2016