HomeUSAStrata Skin Sciences, inc.

Strata Skin Sciences, inc.

USA · Horsham
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, South Korea, Israel — 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
2listed device types
Class I 0Class II 2Class III 0
plus 6 registration records and 2 510(k), 12 PMA
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
1active device licences
Class II 1
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States6 registration records, 2 510(k), 12 PMA, 1 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: Strata Skin Sciences, inc. · STRATA SKIN SCIENCES, INC.

Company information

Country
USA
City
Horsham

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

12018 · K181480
12020 · K193478

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK193478XTRAC Momentum Excimer Laser System2020-01-14
USK181480MMD Tip2018-08-01
CA71839VTRAC EXCIMER ULTRAVIOLET LAMPClass II

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