elos Plus system FG70534

GUDID 00817495024158

elos Plus System, Packaged

Candela Corporation

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system
Primary Device ID00817495024158
NIH Device Record Keyefac69b2-486d-4fc1-9bb5-36b7df963375
Commercial Distribution StatusIn Commercial Distribution
Brand Nameelos Plus system
Version Model NumberFG70534
Catalog NumberFG70534
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com
Phone8007352737
Emailcustomerservice@syneron-candela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495024158 [Primary]
GS107290109950839 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

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

00817495024011 - MSDS DCD Option Kit GMPP2024-07-04 MSDS DCD Option Kit GMPP
00817495023946 - Modified LSDS Fiber Assembly, 12-26 mm2024-06-25 Modified LSDS Fiber Assembly 12-26 mm
00817495023984 - GentleCool Pro Canister Cryogen (R134a / 980g / US)2024-05-31 Canister Cryogen (R134a / 980g / US)
00817495024004 - GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US)2024-05-31 Packaged 15-Pack of Cryogen (R134a / 980g / US)
00817495020587 - Packaged 15-Pack of Cryogen (R134a / 980g / US)2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / US)
00817495023649 - Packaged 15-Pack of Cryogen (R134a / 980g / JP)2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / JP)
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
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