AccessGUDID - DEVICE: Anchorfree (06970441320019)

GUDID

Device Identifier (DI) Information

Brand Name: Anchorfree
Version or Model: L808
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beijing Anchorfree Technology Co., Ltd.

Primary DI Number: 06970441320019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529187417 *Terms of Use

Device Description: The diode laser system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The proposed system provides two working modes, which are standard hair removal mode (HR) and fast hair removal mode (FHR). They are different in the combination of frequency and fluence. Compared with HR mode, the FHR Mode (Fast Hair Removal) has low fluence and high repetition rate (10Hz). The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, including Axillary, Chest, Arm, Back, Leg, Hairline, Cheek, Lip, Beard, and Bikini.

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

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 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 incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing and lesion/hair/tattoo removal; it may also be used for coagulation/haemostasis procedures. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch; it does not include frequency-doubling technology.

GMDN Preferred Term Name

GMDN Definition

Dermatological 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 incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing and lesion/hair/tattoo removal; it may also be used for coagulation/haemostasis procedures. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch; it does not include frequency-doubling technology.

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141973	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: b7733dde-847f-47f8-9538-1978964ebd34
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 12, 2016