AccessGUDID - DEVICE: Laserconn (06972558160045)

GUDID

Device Identifier (DI) Information

Brand Name: Laserconn
Version or Model: Milestone Standard-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Diode Laser Hair Removal System
Company Name: Sanhe Laserconn Tech Co., Ltd.

Primary DI Number: 06972558160045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560439500 *Terms of Use

Device Description: Diode Laser Hair Removal Systems for Medical Use-Milestone Standard-A is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

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?
45221	Dermatological laser beam guiding handpiece	A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222800	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
Storage Environment Temperature: between -40 and 55 Degrees Celsius
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 0 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Width: 379 Millimeter
Length: 388 Millimeter
Height: 888 Millimeter

Device Record Status

Public Device Record Key: 2a6f710f-1dfc-4ff0-bc51-fdb2fd833596
Public Version Date: December 21, 2022
Public Version Number: 1
DI Record Publish Date: December 13, 2022