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Lumenis AcuPulse CO2 Laser Systems - HSA Registration DE0008360

Access comprehensive regulatory information for Lumenis AcuPulse CO2 Laser Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0008360 and owned by Lumenis Ltd. The device was registered on February 03, 2012.

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
DE0008360
Lumenis AcuPulse CO2 Laser Systems
HSA Registration Number: DE0008360
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Product Description

Intended for the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic surgery including GYN laparoscopy, Dental and Oral Surgery, Neurosurgery, with exemption of applications in contact with Central Nervous System, Orthopedics, General Surgery and Podiatry

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0008360
Registration Date
February 03, 2012
Change Notification Approval Date
February 13, 2025
Retention Due Date
February 02, 2026
Product Owner
Short Name
Lumenis Ltd
Address
Yokneam Industrial Park, Hakidma Street 6, P.O.B.#240, Yokneam, 2069204, ISRAEL
Registrant
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model Information
Model Name(s)
MicroSlad 717/718 Lens Slide 400 mm Model: 19110 MicroSlad 719 Lens Slide  250 mm Model: 19102 MicroSlad 719 Lens Slide  200 mm Model: 19101 MicroSlad Lens Slide 300 mm Model: 19103 120° Mirror Tip for Multi-Application Handpiece 90°  Mirror Tip for Multi-Application Handpiece MicroSlad 719 Lens Slide  400 mm Model: 19105 MicroSlad 717/718 Lens Slide 300 mm Model: 19108 MicroSlad 719 Lens Slide  350 mm Model: 19104 MicroSlad 717/718 Lens Slide 400 mm Model: 19109 MicroSlad 717/718 Lens Slide  200 mm Model: 19106 MicroSlad 717/718 Lens Slide  250 mm Model: 19107 MicroSlad 717/718 Lens Slide  275 mm Model: 19120 MicroSlad 719 Lens Slide  275 mm Model: 19119 ColpoSlad 726 Micromanipulator MicroSlad 719 Micromanipulator AcuPulse™ Incisional Handpiece 125 mm ColpoSlad 725 Micromanipulator MicroSlad 715 Micromanipulator BeamAlign Laparoscope Coupler 200mm BeamAlign Laparoscope Coupler 300mm Multi-Application Handpiece Set Nasal probe Starter Kit AcuSpot 712 Micromanipulator Fiber Inserts for Nasal Probes (3 pk) Nasal Probe with Straight Tip Nasal Probe with Straight Tip and  90 Degree Right Mirror Nasal Probe with Straight Tip and  90 Degree  Left Mirror Nasal Probe with Straight Tip and Smoke Evacuation Channel Nasal Probe with Straight Tip,  90 Degree Right Mirror and Smoke Evacuation Channel Nasal Probe with Straight Tip, 90 Degree Left Mirror and Smoke Evacuation Channel Nasal Probe with Bent Tip Nasal Probe with Bent Tip Smoke Evacuation Channel SurgiTouch ™  Scanning Handpiece Set SurgiTouch™  Scanning Handpiece 200mm SurgiTouch™  Scanning Handpiece 260mm SurgiTouch™  Scanning Handpiece 125mm Nasal Probe Coupler for Fiber Insert Laryngeal Probe with Straight Tip Laryngeal Probe with  Straight Tip Smoke Evacuation Channel Laryngeal Probe with Straight Tip, 90 Degree Right Mirror Smoke Evacuation Channel Laryngeal Probe with Straight Tip 90 Degree  Left Mirror Smoke Evacuation Channel Fiber Inserts for Laryngeal Probes (3 pk) OtoScan Ear Aeration System Model: NTSC camera OtoScan Ear Aeration System Model: PAL camera  AcuSpot 712 L Micromanipulator FiberLase HP-M 90 mm malleable FiberLase HP-M 300 mm malleable FiberLase™ Robotic Drop-In Guide FemTouch™, Focus Tip FiberLase™ CO2 Fiber FiberLase HP-R 60 mm straight, curved tip FiberLase HP-R 60mm straight, straight tip FiberLase HP-R 140 mm straight, curved tip FiberLase HP-R 180 mm straight, curved tip FiberLase HP-R 180 mm straight, straight tip FiberLase HP-R 240 mm bent, curved tip FiberLase HP-M 140 mm malleable FiberLase HP-M 240 mm malleable FiberLase™  Handpiece Malleable Kit FiberLase HP-R 240 mm bent, straight tip FiberLase HP-R 140 mm  bent, straight tip FiberLase™  Endoscope Protection Sheath Micro-H™ Otology Kit Micro-G™ Otology Kit MicroLase™ Fiber OtoLase™ Straight HP OtoLase™ Curved HP FemTouch™ Standard Panoramic FemTouch™ Fine Panoramic FemTouch™ Standard Focus FemTouch™ Fine Focus OtoLase™ Fiber OtoLase™ Straight Tips Package OtoLase™ Curved Tips Package FemTouch™ Fine 3rd Lens Holder Upgrade AcuSpot 712 Z Micromanipulator AcuPulse AcuPulse 40WG AcuPulse DUO™ SurgiTouch Scanner Model: kit for AcuPulse and AcuPulse DUO AcuPulse DUO HW Upgrade kit AcuPulse to DUO Model: Kit with prolonged arm AcuPulse DUO HW Upgrade Kit AcuPulse to DUO Model: Kit without prolonged arm AcuPulse DUO HW Upgrade kit AcuPulse 40WG to DUO AcuScan 120 Microscanner Upgrade Kit DeepFX™ Disposable Tips SurgiTouch Scanner Model: Upgrade kit for AcuPulse 30/40 to 30/40 ST AcuScan 120 Microscanner AcuScan 120 Upgrade Kit AcuScan 120 Microscanner Kit Digital AcuBlade™ Upgrade kit for AcuPulse™ MicroSwitch Joystick FiberLase™ Handpiece Rigid Kit FiberLase™  Accessory Starter Kit with FiberLase Fiber Digital AcuBlade Upgrade Kit SurgiTouch™ Scanner FiberLase™ Robotic Drop-In Guide Surgitouch Upgrade Kit For Acupulse DUO, replacement AcuScan 120 Microscanner Kit, replacement FemTouch™ Focus Tip AcuPulse Upgrade Kit 40 to 40ST AcuPulse Upgrade Kit 40 to 40F AcuPulse Upgrade Kit 30 To 30ST AcuPulse Upgrade Kit 40ST to 40 AES-A AcuPulse Upgrade Kit 40AES-R To 40AES-A AcuPulse Upgrade Kit 40 to 40AES-R AcuPulse Upgrade Kit 40AES-F to 40AES-A AcuPulse Upgrade Kit 40 To 40AES-A AcuPulse Upgrade Kit 40AES-F to 40AES-R AcuPulse Upgrade Kit to AES-A 4 Modes Upgrade AcuPulse Upgrade Kit to AES-R 4 Modes Upgrade
Model Identifier(s)
AA0192700 AA0192800 AA0192900 AA0193000 AA0198800 AA0198900 AA0205000 AA0222800 AA0252700 AA0252800 AA0400400 AA0402500 AA0590400 AA0590500 AA0631700 AA0631900 AA0632600 AA0852000 AA0886700 AA2330500 AA2330600 AA2377300 AA2603300 AA2630000 AA2756300 AA2756500 AA2756600 AA2756700 AA2756800 AA2756900 AA2757000 AA2757100 AA2757200 AA2775200 AA2778200 AA2782600 AA2814900 AA2819400 AA2891400 AA2891500 AA2891600 AA2891700 AA2891800 AA2940000 AA2960000 AA3042000 AC-0001100 AC-0001200 AC-0001300 AC-1007415 AC-1059590 AC-1063920 AC-1063930 AC-1063940 AC-1063960 AC-1063970 AC-1063980 AC-1083940 AC-1083950 AC-1083960 AC-1083970 AC-1083980 AC-1094030 AC-1148090 AC-1148100 AC-1148120 AC-2003612 AC-2003613 AC-2005209 AC-2005210 AC-2005211 AC-2005212 AC-20055370 AC-20055380 AC-20055390 AC-2006500 AC0020170 GA-0000070 GA-0000140 GA-1000000 KT-1000100 KT-1001616 KT-1001617 KT-1001618 KT-1001731 KT-1005870 KT-1023140 KT-1034490 KT-1037260 KT-1037270 KT-1042800 KT-1044100 KT-1061370 KT-1064910 KTCE03300 SA-1023230 SA-1115060 SPN-1028780 SPN-1028790 SPSA-20002590 UG-0000300 UG-0000320 UG-0000340 UG-0000350 UG-0000360 UG-0000370 UG-0000380 UG-0000390 UG-0000580 UG-1149910 UG-1149920