AccessGUDID - DEVICE: Diode Laser System Whitening Handpiece (00647529002520)

GUDID

Device Identifier (DI) Information

Brand Name: Diode Laser System Whitening Handpiece
Version or Model: 7400022 Refurbished
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Biolase, Inc.

Primary DI Number: 00647529002520
Issuing Agency: GS1
Commercial Distribution End Date: September 11, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 152165700 *Terms of Use

Device Description: A reusable hand-held device intended for use with Diode Laser Systems in tooth whitening procedures. The device is used with disposable protective shields.

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?
60409	Musculoskeletal/physical therapy laser, professional	An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121286	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: c3e3e5e8-61db-4ec8-8f4a-24bdaf3386fc
Public Version Date: June 12, 2023
Public Version Number: 9
DI Record Publish Date: September 22, 2016