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G.N.S neoLaser neoV Laser - HSA Registration DE0509662

Access comprehensive regulatory information for G.N.S neoLaser neoV Laser in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509662 and owned by G.N.S. neoLaser Ltd.. The device was registered on August 16, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0509662
G.N.S neoLaser neoV Laser
HSA Registration Number: DE0509662
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Product Description

The neoV diode laser family are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. Dermatology, Proctology, Phlebology, Otolaryngology, Pulmonology, Thoracic Surgery, General Surgery, Gastroenterology, Orthopedics, Neurosurgery, Dentistry, Gynecology, Urology, and Podiatry.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0509662
Registration Date
August 16, 2024
Retention Due Date
August 15, 2025
Product Owner
Short Name
G.N.S. neoLaser Ltd.
Address
7 HaEshel Street, Caesarea, 3088900, ISRAEL
Registrant
Address
28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Importer
Address
3006 UBI ROAD 1, KAMPONG UBI INDUSTRIAL ESTATE, #02-336, SINGAPORE 408700
Model Information
Model Name(s)
neoV 1470nm Laser System, 12W, 650nm aiming beam, NC neoV 1470nm Laser System, 12W, 635nm aiming beam, NC neoV 1064nm Laser System, 12W, 650nm aiming beam, NC neoV 1064nm Laser System, 24W, 650nm aiming beam, NC neoV 1940nm Laser System, 6W, 635nm aiming beam, NC neoV 1940nm Laser System, 6W, 650nm aiming beam, NC neoV 810nm Laser System, 28W, 650nm aiming beam, NC neoV 980nm Laser System, 28W, 650nm aiming beam, NC neoV 980nm Laser System, 28W, 635nm aiming beam, NC neoV 1470nm Laser system, 12W, 650nm, EU, NC, with accessories neoV 1470nm Laser system, 12W, 635nm, EU, NC, with accessories neoV 1064nm Laser system, 12W, 650nm, EU, NC, with accessories neoV 1064nm Laser system, 24W, 650nm, EU, NC, with accessories neoV 1940nm Laser system, 6W, 635nm, EU, NC, with accessories neoV 1940nm Laser system, 6W, 650nm, EU, NC, with accessories neoV 810nm Laser system, 28W, 650nm, EU, NC, with accessories neoV 980nm Laser system, 28W, 650nm, EU, NC, with accessories neoV 980nm Laser system, 28W, 635nm, EU, NC, with accessories Laser Surgery Fiber 600um NA 0.37, 2.5m CORONA 360 600 microns 1.8mm 2.5m Fused CORONA 360 400 microns 1.3mm 2.5m Fused CORONA Hemorrhoid Probe 2.5m CORONA Fistula Probe 2.5m 600um CORONA Infinite Ring Fiber 1.8mm 2.5m Fused CORONA Infinite Ring Fiber 1.6mm 2.5m Fused CORONA Infinite Ring Fiber 1.3mm 2.5m Fused CORONA Infinite Ring Fistula Probe 2.5m CORONA Infinite Ring Hemorrhoid Probe 2.5m
Model Identifier(s)
BG14700 BG14702 BG16400 BG16402 BG19400 BG19402 BG81000 BG98000 BG98001 NV14704 NV14705 NV16404 NV16405 NV19400 NV19402 NV81002 NV98004 NV98005 OF99014 OF99019 OF99024 OF99025 OF99028 OF99040 OF99041 OF99042 OF99043 OF99044