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Surgical Laser Incorporated

USA · Miami

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

61510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 61 510(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

7active device licences

Class II 2Class III 5

15 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States0 registration records, 61 510(k), 0 PMA, 130 excluded

Brazil0 confirmed, 14 excluded

Canada7 confirmed, 17 excluded

Manufacturer names merged into this page: PHOTOMEDEX, INC. ALSO D.B.A. SURGICAL LASER TECHNOLOGIES

Same-named companies — This database also contains companies with near-identical names: PHOTOMEDEX, INC. ALSO D.B.A. SURGICAL LASER TECHNOLOGIES, Surgical Laser Technologies, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151855	SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber	2016-04-15
US	K042211	MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS	2004-11-08
US	K023624	SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921	2003-01-27
CA	28819	SLT CLMD SURGICAL LASER ASPIRATION HANDPIECES AND WANDS	Class II
CA	30150	SLT CLMD SURGICAL LASER	Class III
CA	38525	LASERPRO CTH HOLMIUM LASER	Class III

Surgical Laser Incorporated

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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