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Lumenis VersaPulse PowerSuite Holmium and Dual Wavelength Laser System - HSA Registration DE0013395

Access comprehensive regulatory information for Lumenis VersaPulse PowerSuite Holmium and Dual Wavelength Laser 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 DE0013395 and owned by Lumenis Ltd. The device was registered on July 17, 2013.

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
DE0013395
Lumenis VersaPulse PowerSuite Holmium and Dual Wavelength Laser System
HSA Registration Number: DE0013395
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Product Description

Specific to the Ho: YAG WaveleAngth: intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Arthroscopy, Urology, Urinary lithotripsy, Endonasal surgery, Gynecological surgery, General surgery, Gasteroenterological surgery Specific to the Nd: YAG Wavelength: intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Urology, General surgery, Gastroenterology, Thoracic and pulmonary surgery, E.N.T. surgery, Podiatry, Gynecology—The use of the Nd:YAG wavelength in Gynecology is limited to specific indications.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0013395
Registration Date
July 17, 2013
Change Notification Approval Date
February 13, 2025
Retention Due Date
July 16, 2025
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)
Sterilization Tray VersaTip 0° VersaTip 15° VersaTip 30° VersaTip 70° DuoTome SideLite 550 InfraTome 0° InfraTome 15° InfraTome 30° SlimLine 365 SlimLine 550 VersaLink DiskeTome SlimLine 200 SlimLine 1000 Sterilization Tray InfraTome SideLite Accessory Bag VersaPulse Powersuite 80W/100W Holmium Nd:YAG VersaPulse Powersuite 100 W Holmium Laser VersaPulse Powersuite 60 W Holmium Laser Remote Control Kit SlimLine EZ 200 SlimLine EZ 365 SlimLine EZ 550 SlimLine GI 365 Fiber Cleaving Tool Stripper 550 - Slimline 550 Ceramic Scissors Stripper 1000- Slimline 1000 Stripper 365 - Slimline 365 Stripper 200- Slimline 200 Eyewear, Safety, Laser Eyewear, Safety, Laser Fiber Inspection Scope
Model Identifier(s)
0619-760-01 0622-651-00 0622-651-15 0622-651-30 0622-651-70 0623-703-01 0624-084-00 0624-084-15 0624-084-30 0624-148-36 0624-149-55 0624-175-01 0624-829-01 0626-221-20 0627-497-01 0627-920-01 0629-380-70 0629-599-01 0638-800-00 0638-803-00 0638-804-00 0638-847-01 0642-393-01 0642-394-01 0642-395-01 0642-431-01 5402-0141 5402-0151 5402-0152 5402-0159 5402-0163 5402-0164 MD1662500 MD1662600 SA-1065500