Pure Global

Lumenis Pulse Systems - HSA Registration DE0501797

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0501797
Lumenis Pulse Systems
HSA Registration Number: DE0501797
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 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)
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