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Vydence Medical

Brazil · Sao Carlos

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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

4listed device types

Class I 0Class II 4Class III 0

plus 8 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States8 registration records, 6 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: Vydence Medical Industria e Comercio Ltda · VYDENCE MEDICAL - INDUSTRIA E COMERCIO LTDA · VYDENCE MEDICAL - INDUSTRIA E COMERCIO LTDA.

Same-named companies — This database also contains companies with near-identical names: VYDENCE MEDICAL - INDUSTRIA E COMERCIO LTDA.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12018 · K171443

12019 · K190007

12021 · K202998

12022 · K220041

12024 · K242534

12026 · K252753

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252753	Vydence Family of Lasers	2026-01-24
US	K242534	HandPICO Fractional Laser Handpiece Tip	2024-12-20
US	K220041	HandPICO	2022-05-05
BR	80058589010	Sistema a LED para Terapia	Class II
BR	80058589006	Aparelho eletromédico de radiofrequência fracionado por microagulhamen	Class II
BR	80058589003	APARELHO ELETROMÉDICO DE TERAPIA POR RESFRIAMENTO DO AR	Class II

Vydence Medical

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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