HomeUSAIPG MEDICAL CORPORATION

IPG MEDICAL CORPORATION

USA · Marlborough
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Australia, Israel — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 7 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 1IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 3 510(k), 0 PMA
Manufacturer names merged into this page: IPG MEDICAL CORPORATION

Company information

Country
USA
City
Marlborough

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22024 · K233344
12025 · K251100

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251100IPGTFL-022025-09-19
USK233344Regenalase Laser System2024-05-28
USK232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories2024-03-21

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