Vbeam Platinum

Basic Information

• Brand Name: Vbeam Platinum
• Primary DI: 00817495020143
• Version / Model: 9914-00-0310
• Company Name: Candela Corporation
• Labeler DUNS: 053468385
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: 7ba08e08-9480-43f9-8e0e-b28f2f7027e4

Device Description

Pulsed Laser

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57890	Dermatological dye laser system	A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite organic compounds (i.e., dye) used as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation to incise, excise, ablate, and vaporize soft tissues for dermatological applications such vascular/skin lesion, acne and wrinkle removal or reduction. It typically includes a light source, flexible fibreoptic delivery/positioning device(s), and controls/foot-switch for pulsed mode operation. During emission the dye has to be optically excited by another light source (e.g., another laser or flash lamp).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817495020143	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K230990	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 40 – 110 Degrees Fahrenheit