Lens, Gold & Silver AS92041

GUDID 00817495024479

Lens, Gold & Silver Assy, CO2RE

Candela Corporation

Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system
Primary Device ID00817495024479
NIH Device Record Keycd33d39e-bc3f-4df9-8ac7-a5d384c16f2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLens, Gold & Silver
Version Model NumberAS92041
Catalog NumberAS92041
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495024479 [Primary]
GS107290109950273 [Previous]

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

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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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