Pure Global

Lumenis Lumenis Pulse 60H System - HSA Registration DE0508812

Access comprehensive regulatory information for Lumenis Lumenis Pulse 60H 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 DE0508812 and owned by Lumenis Ltd. The device was registered on January 05, 2024.

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
DE0508812
Lumenis Lumenis Pulse 60H System
HSA Registration Number: DE0508812
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Lumenis Pulse 60H system with Delivery Devices and Accessories are 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
Gastroenterology & Urology
Registration Information
Registration Number
DE0508812
Registration Date
January 05, 2024
Change Notification Approval Date
March 18, 2025
Retention Due Date
January 04, 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
Model Information
Model Name(s)
SlimLine™ SIS 200 LP SlimLine™ SIS 365 LP SlimLine™ SIS EZ 200 LP SlimLine™ SIS EZ 365 LP SlimLine™ 200 D/F/L LP SlimLine™ SIS 550 LP SlimLine™ SIS EZ 550 LP SlimLine™ SIS 1000 LP Moses™ 200 D/F/L LP Moses™ 365 D/F/L LP Moses™ 550 D/F/L LP Lumenis Pulse™ 60H, 50Hz Dual Foot Pedal Kit
Model Identifier(s)
AC-1001636 AC-1001637  AC-1001638 AC-1001639 AC-1001640 AC-1001680 AC-1001690 AC-1001700 AC-1003040 AC-1003050 AC-1003060 GA-2006378 KT-1003512 Dual Foot Pedal Kit