AccessGUDID - DEVICE: Kit, PicoWay 532 HE Resolve HP (00817495022901)

GUDID

Device Identifier (DI) Information

Brand Name: Kit, PicoWay 532 HE Resolve HP
Version or Model: 7123-00-0593
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Candela Corporation

Primary DI Number: 00817495022901
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053468385 *Terms of Use

Device Description: Handpiece Kit

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:	Yes
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?
65509	Dermatological laser beam producing handpiece	A hand-held component of a professional, high-powered, dermatological laser system designed to both generate and direct a therapeutic laser (diode laser) for dermatological applications (e.g., hair removal, treatment of dermal lesions). This device is connected to a control unit which supplies power to the handpiece and allows control of the treatment. 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 [?]
K220853	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: 7d9984cb-7867-477d-8e00-a13d252ffb88
Public Version Date: February 16, 2024
Public Version Number: 7
DI Record Publish Date: December 12, 2019