HomeUSALensar, Inc.

Lensar, Inc.

USA · Orlando
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Israel — 6 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
3listed device types
Class I 0Class II 3Class III 0
plus 14 registration records and 14 510(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
1 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
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 States14 registration records, 14 510(k), 0 PMA
Manufacturer names merged into this page: LENSAR, Inc · LENSAR, INC.

Company information

Country
USA
City
Orlando

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.

Business registration

CIK
0001320350
Registration status
Active
Listing status
Listed (LNSR)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12010
22011
22012
12013
22015
22017
32018
12022

FDA listed device types

Unit, Phacofragmentation 1Ophthalmic Femtosecond Laser 1Laser, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220259ALLY Adaptive Cataract Treatment System2022-06-09
USK182795LENSAR Laser System - fs 3D (LLS-fs 3D)2018-12-21
USK181430LENSAR Laser System - fs 3D (LLS-fs 3D)2018-08-09

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