Applicator Frax 1940 1940 nm

GUDID 00817495023427

CANDELA CORPORATION

Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system
Primary Device ID00817495023427
NIH Device Record Keyef4e95bd-95a2-41d5-b5b3-0dee9be20075
Commercial Distribution StatusIn Commercial Distribution
Brand NameApplicator Frax 1940 1940 nm
Version Model Number9APP7908-CNDL
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495023427 [Primary]

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 Date2021-01-25
Device Publish Date2021-01-15

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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)

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