ALCON Centurion® Vision System - HSA Registration DE0016348

Access comprehensive regulatory information for ALCON Centurion® Vision System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016348 and owned by ALCON LABORATORIES INC. The device was registered on September 19, 2014.

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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HSA Official Data

CLASS C

DE0016348

ALCON Centurion® Vision System

HSA Registration Number: DE0016348

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Product Description

The Centurion® Vision System is indicated for emulsification, separation, irrigation and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Device Classification

Device Class

CLASS C

Medical Speciality Area

Ophthalmology

HSA Product Code

HSAMDC00108

HS Code

90185000

Registration Information

Registration Number

DE0016348

Registration Date

September 19, 2014

Change Notification Approval Date

January 03, 2025

Retention Due Date

September 18, 2025

Product Owner

Name

ALCON LABORATORIES INC

Short Name

ALCON LABORATORIES INC

Address

6201 SOUTH FREEWAY, FORT WORTH TEXAS 76134, UNITED STATES

Registrant

Name

ALCON PTE LTD

Address

1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628

Importer

Name

ALCON PTE LTD

Address

1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628

Model Information

Model Name(s)

I/A Tip 0.3 mm Small Bore I/A Tip 0.3 mm Bent Centurion Vision System 30° Round, 0.9 mm MicroTip Flared ABS® 45deg Round, 0.9 mm MicroTip Flared ABS 30deg Kelman, 0.9 mm MicroTip Flared ABS 45deg Kelman, 0.9 mm MicroTip Flared ABS Silicone I/A Tip, 0.3mm Bent Silicone I/A Tip, 0.3mm Straight 30deg Round, 0.9 mm Tapered ABS 45deg Round, 0.9 mm Tapered ABS 30deg Kelman, 0.9 mm Tapered ABS 45deg Kelman, 0.9 mm Tapered ABS Infiniti Ozil, HP 30deg Kelman, 0.9 mm Mini Flared ABS 45deg Kelman, 0.9 mm Mini Flared ABS Assy, Ship, UltraVit 20 GA, 5000 CPM Assy, Ship, UltraVit 23 GA, 5000 CPM Assy, Ship, UltraVit 25 GA, 5000 CPM INTREPID I/A Tip, 0.3mm, Straight INTREPID I/A Tip, 0.3mm Bent Assy, Ship, UltraVit 20 GA, 2500 CPM Assy, Ship, UltraVit 23 GA, 2500 CPM Assy, Ship, UltraVit 25 GA, 2500 CPM 30deg OZil 12, 0.9 mm Mini Flared ABS 45deg OZil 12, 0.9 mm Mini Flared ABS 30deg Reverse OZil 12, 0.9 mm Mini Flared ABS Assy, Ship, Inf UltraVit 23 GA FE Assy, Ship, UltraVit 25+, 2500 CPM Assy, Ship, UltraVit 25+, 5000 CPM Assy, Ship, Inf UltraVit 23 GA FE INTREPID® Polymer I/A Tip, Straight INTREPID® Polymer I/A Tip, Angled INTREPID® Polymer I/A Tip, Curved Assy, Ship, Anterior UltraVit 23 GA, 5000 CPM Assy, Ship, UltraVit 25 GA, 7500 CPM Assy, Ship, UltraVit 25+, 7500 CPM Assy, Ship, UltraVit 23 GA, 7500 CPM Intrepid AutoSert IOL Injector Centurion Ozil, HP Centurion Footswitch Centurion Remote Control Intrepid AutoSert IOL Injector Wrench Intrepid AutoSert IOL Injector Plunger Alcon UltraChopper Tip Ultraflow™* II Handpiece INTREPID® Coaxial Polymer I/A Handpiece – Flared Tip, Straight INTREPID® Coaxial Polymer I/A Handpiece – Flared Tip, Angled INTREPID® Coaxial Polymer I/A Handpiece – Flared Tip, Curved INTREPID® Bimanual Polymer I/A Set 30deg Kelman, 0.9 mm Mini ABS 45° Kelman®, 0.9 mm Mini ABS® Assy, Ship, Cent UVIT Tray UPS Assy, Ship, Cent UltraVit 23GA INTREPID® Coaxial Polymer I/A Handpiece – Tapered Tip, Straight INTREPID® Coaxial Polymer I/A Handpiece – Tapered Tip, Angled INTREPID® Coaxial Polymer I/A Handpiece – Tapered Tip, Curved Active FMS Basic Active FMS Pack, 0.9 mm MicroSmooth Tipless Active FMS Pack, 0.9 mm INTREPID Ultra Tipless Active FMS Pack, 0.9 mm INTREPID Nano Tipless Active FMS Pack, 0.9 mm ABS 30deg Kelman Active FMS Pack, 0.9 mm ABS 45deg Kelman Active FMS Pack, 0.9 mm Tapered ABS 30deg Kelman Active FMS Pack, 0.9 mm Tapered ABS 45deg Kelman Active FMS Pack, 0.9 mm Mini-Flared ABS 30deg Kelman Active FMS Pack, 0.9 mm Mini-Flared ABS 45deg Kelman Active FMS Pack, 0.9 mm Mini-Flared ABS 30deg OZil Active FMS Pack, 0.9 mm Mini-Flared ABS 45deg OZil Active FMS Pack, 0.9 mm INTREPID Ultra, Mini-Flared ABS 30deg Kelman Active FMS Pack, 0.9 mm INTREPID® Ultra, Mini-Flared ABS® 45° Kelman® Active FMS Pack, 0.9 mm INTREPID® Ultra, Mini-Flared ABS® 30° OZil® Active FMS Pack, 0.9 mm INTREPID® Ultra, Mini-Flared ABS® 45° OZil®. Active FMS Pack, 0.9 mm INTREPID® Nano, Mini-Flared ABS® 30° Kelman® Active FMS Pack, 0.9 mm INTREPID® Nano, Mini-Flared ABS® 45° Kelman® Active FMS Pack, 0.9 mm INTREPID® Nano, Mini-Flared ABS® 30° OZil® Active FMS Pack, 0.9 mm INTREPID® Nano, Mini-Flared ABS® 45° OZil® Active FMS Pack, 0.9 mm INTREPID® Ultra, ABS® INTREPID® Balanced 30° Active FMS Pack, 0.9 mm INTREPID® Ultra, ABS® INTREPID® Balanced 45°. Active FMS Pack, 0.9 mm INTREPID® Nano, ABS® INTREPID® Balanced 30° Active FMS Pack, 0.9 mm INTREPID® Nano, ABS® INTREPID® Balanced 45° Gravity FMS Pack, Basic Gravity FMS Pack, 0.9 mm Tipless Gravity FMS Pack, 0.9 mm INTREPID® Ultra Tipless Gravity FMS Pack, 0.9 mm INTREPID® Nano Tipless Gravity FMS Pack, 0.9 mm INTREPID® Ultra, ABS® INTREPID® Balanced 30° Gravity FMS Pack, 0.9 mm INTREPID® Ultra, ABS® INTREPID® Balanced 45° Active FMS Pack, 0.9 mm INTREPID® Ultra, ABS® Mini 30° Kelman® Active FMS Pack, 0.9 mm INTREPID® Ultra, ABS® Mini 45° Kelman® Active FMS Pack, 0.9 mm INTREPID® Nano, ABS® Mini 30° Kelman®. Active FMS Pack, 0.9 mm INTREPID® Nano, ABS® Mini 45° Kelman® INTREPID Transformer I/A Active Sentry Handpiece Active FMS Pack, 0.9 mm MicroSmooth Balanced 30° Active FMS Pack, 0.9 mm MicroSmooth Balanced 45° Centurion Vision System Active FMS W/ Intrepid Ultra Sleeves Active FMS w/Intrepid Ultra Sleeves Active FMS W/ Intrepid Nano Sleeves Active FMS w/Intrepid Nano Sleeves Gravity FMS W/ Intrepid Ultra Sleeves Gravity FMS w/Intrepid Ultra Sleeves Gravity FMS W/ Intrepid Nano Sleeves Gravity FMS w/Intrepid Nano Sleeves Active FMS W/ 0.9MM Infusion Sleeves Active FMS w/0.9mm Infusion Sleeves Gravity FMS W/ 0.9MM Infusion Sleeves Gravity FMS w/0.9mm Infusion Sleeves 45deg Round, 0.9 mm ABS 30deg Kelman, 0.9 mm ABS 45deg Kelman, 0.9 mm ABS ULTRAFLOW S/P Straight Tip, 0.3mm. Ultraflow™* Tip Protector, Standalone ULTRAFLOW S/P 45o Bent Tip, 0.3mm ULTRAFLOW S/P 90o Bent Tip, 0.3mm Ultraflow S/P Irrigation Handpiece ULTRAFLOW S/P Curved Tip, 0.3mm

Model Identifier(s)

356-1007 356-1010 8065000565 8065740837 8065740838 8065740839 8065740840 8065740969 8065740970 8065750261 8065750262 8065750263 8065750264 8065750469 8065750852 8065750853 8065750948 8065750949 8065750950 8065751012 8065751013 8065751017 8065751018 8065751019 8065751176 8065751177 8065751178 8065751197 8065751436 8065751438 8065751479 8065751510 8065751511 8065751512 8065751561 8065751569 8065751570 8065751571 8065751755 8065751761 8065751762 8065751774 8065751775 8065751776 8065751789 8065751795 8065751919 8065751920 8065751921 8065751922 8065752065 8065752066 8065752133 8065752134 8065752144 8065752145 8065752146 8065752180 8065752181 8065752182 8065752183 8065752184 8065752185 8065752186 8065752187 8065752188 8065752189 8065752190 8065752191 8065752192 8065752193 8065752194 8065752195 8065752196 8065752197 8065752198 8065752199 8065752200 8065752201 8065752202 8065752203 8065752212 8065752213 8065752214 8065752215 8065752216 8065752217 8065752244 8065752245 8065752246 8065752247 8065752885 8065752914 8065752917 8065752918 8065753057 8065753134 8065753135 8065753136 8065753137 8065753142 8065753143 8065753144 8065753145 8065753158 8065753159 8065753160 8065753161 8065790021 8065790022 8065790023 8065817001 8065817002 8065817201 8065817301 8065817501 8065817601