HomeUSALumenis Be, Ltd.

Lumenis Be, Ltd.

USA · Yokneam
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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
7listed device types
Class I 1Class II 6Class III 0
plus 16 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
4 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
16 including historic records
TWTaiwanTFDA
14valid device licences
Class II 14
SGSingaporeHSA SMDR
3device registrations
CLASS C 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
19active ARTG entries
Class I 3IIa 1IIb 14Class Is (sterile) 1
HKHong KongMDACS
2valid listings
Class III 2
ILIsraelAMAR
12registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 1
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 States16 registration records, 7 510(k), 0 PMA, 4 excluded
Brazil0 confirmed, 3 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: LUMENIS BE INC. · Lumenis Be Ltd · LUMENIS BE LTD. · LUMENIS BE, INC. · LUMENIS BE LTD

Company information

Country
USA
City
Yokneam

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

22022 · K220877
22023 · K233301
12024 · K242349
12025 · K250809
12026 · K253803

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Intense Pulsed Light Device For Managing Dry Eye 1Laser, Ophthalmic 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Powered Laser Surgical Instrument 1Laser, Comb, Hair 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253803MILAN System2026-06-02
USK250809Stellar M222025-04-16
USK242349FoLix2024-09-09

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