SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape III KT75072

GUDID 00817495024561

SA Repl. Med. Cvr. 25x30mm (4 Hr), Velashape III

Candela Corporation

Multi-modality skin contouring system
Primary Device ID00817495024561
NIH Device Record Key144cf32d-afbf-4454-ae56-344e6e26cc31
Commercial Distribution StatusIn Commercial Distribution
Brand NameSA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape III
Version Model NumberKT75072
Catalog NumberKT75072
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495024561 [Primary]
GS110817495024568 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

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

00817495023960 - Nordlys Mini2025-03-18 Nordlys Mini Laser System
00817495023526 - 1940 Applicator2025-03-14 1940 applicator (1940 nm) for Nordlys and Nordlys Mini
00817495023953 - 1550 Applicator 2025-03-14 1550 Applicator (1550 nm) for Nordlys and Nordlys Mini
00817495024059 - Vbeam Prima Pro Laser System2025-01-23 Vbeam Prima Pro Laser System Nd: YAG Configuration 1064, 595, DCD
00817495025247 - Vbeam Prima Pro DCD Handpiece2025-01-23 ASSY, DCD HP, DELIVERY SYSTEM, VBEAM PRIMA PRO
00817495024677 - PicoWay Laser System2024-10-21 PicoWay Laser System
00817495023540 - PicoWay Laser System2024-10-14 Picoway Laser System
00817495023663 - PicoWay Laser System2024-10-14 Picoway Laser System

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.