Vcontour applicator FG71012

GUDID 00817495022727

Vcontour Applicator, Velashape III

Candela Corporation

Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system
Primary Device ID00817495022727
NIH Device Record Key628aac81-385e-4fbd-8aed-5a3f5b6ef6be
Commercial Distribution StatusIn Commercial Distribution
Brand NameVcontour applicator
Version Model NumberFG71012
Catalog NumberFG71012
Company DUNS053468385
Company NameCandela Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com
Phone800-735-2737
Emailcustomerservice@syneron-candela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495022727 [Primary]
GS107290109950396 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUVMassager, Vacuum, Light Induced Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

Devices Manufactured by Candela Corporation

00817495024370 - Profound, SubQ Single- Use Cartridge, Packaged2024-03-08 Profound, SubQ Single- Use Cartridge, Packaged
00817495024387 - Profound, Dermal Single- Use Cartridge, Packaged2024-03-08 Profound, Dermal Single- Use Cartridge, Packaged
00817495023854 - GMPP Modified LSDS (HRDS) Options Kit for DCD2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for DCD
00817495023915 - GMPP Modified LSDS (HRDS) Options Kit for ACC2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for ACC
00817495025032 - HRDS Handpiece DCD Cooled2024-02-28 HRDS Handpiece DCD Cooled
00817495025049 - HRDS Handpiece Air Cooled2024-02-28 HRDS Handpiece Air Cooled
00817495024882 - Canister HFO-R1234 ZE / 950g, ALUM (US)2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (US)
00817495024905 - Canister HFO-R1234 ZE / 950g, ALUM (Japan)2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (Japan)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.