SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III

Basic Information

• Brand Name: SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III
• Primary DI: 00817495024578
• Version / Model: KT75672
• Catalog Number: KT75672
• Company Name: Candela Corporation
• Labeler DUNS: 053468385
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-20
• Public Version: 1
• Public Version Date: 2023-10-30
• Public Version Status: New
• Public Device Record Key: fa647475-cc33-4aba-b945-6a35b5958441

Device Description

SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44832	Multi-modality skin contouring system	An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817495024578	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122579	000