Singapore HSA registration DE0501797
Lumenis Pulse Systems
Singapore·CLASS C·Lumenis Ltd.·Registered June 28, 2018Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0501797
- Registration Date
- June 28, 2018
- Change Notification Approval Date
- February 13, 2025
- Retention Due Date
- June 27, 2026
Product description
The Lumenis Pulse systems with delivery devices and accessories 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; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.
Product Owner
- Name
- Lumenis Ltd.
- 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)
- Slimline GI SIS 365 Fiber Slimline SIS 1000 Fiber Slimline EZ SIS 200 Fiber Slimline SIS 200 Fiber Slimline EZ SIS 365 Fiber Slimline SIS 365 Fiber Slimline EZ SIS 550 Fiber Slimline SIS 550 Fiber Xpeeda DSL Fiber SlimLine™ 200 D/F/L Moses™ 200 D/F/L Moses™ 365 D/F/L Moses™ 550 D/F/L Aspiration Kit 6 Pack Aspiration Kit Aspiration Tube Lumenis Pulse 120H Lumenis Pulse 120H Lumenis Pulse 120H Lumenis Pulse 120H Lumenis Pulse 100H Lumenis Pulse 50H Lumenis Pulse 30H Lumenis Pulse 120H Lumenis Pulse 30H
- Model Identifier(s)
- 0644-007-01 0644-008-01 0644-016-01 0644-017-01 0644-018-01 0644-019-01 0644-020-01 0644-021-01 AC-1000729 AC-1001635 AC-10030100 AC-10030110 AC-10030120 AC-1141660 AC-1141940 AC-2003592 GA-0006900 GA-0006902 GA-0008700 GA-0008800 GA-1008942 GA-1008943 GA-2000435 GA-2003477 GA-2006098
About this record
Access comprehensive regulatory information for Lumenis Pulse 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 DE0501797 and owned by Lumenis Ltd.. The device was registered on June 28, 2018.
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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