Excimer Laser System

Product Code: LZS

Medical Laser Products

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as LZS

4439Excimer Laser System

Total Product Life Cycle (TPLC) Devices

4439Excimer Laser System

FDA Consensus Standards

Excimer Laser System [32410]21 CFR Unclassified 🔎
Excimer Laser System [29297]21 CFR Unclassified 🔎
Excimer Laser System [32150]21 CFR Unclassified 🔎
Excimer Laser System [37870]21 CFR Unclassified 🔎

Pre-market Approvals for LZS

P980008LASERSCAN LSX EXCIMER LASERLASERSIGHT TECHNOLOGIES, INC.
P990027TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALITECHNOLAS PERFECT VISION GMBH
P970053Nidek EC-5000 Excimer Laser SystemNIDEK CO., LTD.
P930016iDESIGN Refractive Studio; STAR Excimer Laser SystemAMO Manufacturing USA, LLC
P910062STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio SystemAMO Manufacturing USA, LLC
P990010STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio SystemAMO Manufacturing USA, LLC
P020050ALLEGRO Topolyzer VARIO and Patient Bed SwivelAlcon Laboratories, Inc.
P030008WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed SwivelAlcon Laboratories, Inc.

Global Unique Device Identification Database

00380659909634Excimer laser system
00380659908965Excimer Laser System
00380659908170Excimer Laser System
00380659908163Excimer Laser System
00380659907944Excimer Laser System
00380659907678Excimer Laser System
00380659907463Excimer Laser System
00380659906060Excimer Laser System
05050474651456Excimer laser system
05050474651449Excimer laser system
05050474651432Excimer laser system
05050474620278Excimer laser system
05050474591912Excimer laser system
05050474591905Excimer laser system
05050474573444Excimer laser system

Maude Adverse Events

WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-31
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-31
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-31
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-31
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-31
STARJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-30
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-30
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-30
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-30
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-30
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-30
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-30
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-30
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-30
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-30
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-30
S4-IR-ETLJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-27
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-27
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-26
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-26
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-26
S3EXCIMER LASERJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-26
STARJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-26
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-24
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-23
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-23
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-23
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-23
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-23
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-23
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-20
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-20
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-18
S4-IR-ETLJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-18
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-18
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-18
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-18
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-18
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-18
LASIK LASER DEVICEUNK2020-03-17
LASIK LASER DEVICEUNK2020-03-17
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-17
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-17
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-17
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-16
ALLEGRETTO WAVE EYE-Q EXCIMER LASERWAVELIGHT GMBH2020-03-16
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-16
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-16
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-13
WAVELIGHT EX500 EXCIMER LASERWAVELIGHT GMBH2020-03-13
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