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Lumenis Stellar M22 Aesthetic Treatment System - HSA Registration DE0506011

Access comprehensive regulatory information for Lumenis Stellar M22 Aesthetic Treatment 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 DE0506011 and owned by Lumenis Ltd.. The device was registered on July 26, 2021.

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
DE0506011
Lumenis Stellar M22 Aesthetic Treatment System
HSA Registration Number: DE0506011
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Product Description

The Lumenis Stellar M22 system has connection capability with Universal IPL (spectrum of 400-1200nm with different filters) that is indicated for cutaneous lesions, including warts, and mild to moderate inflammatory acne (Acne Vulgaris).

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0506011
Registration Date
July 26, 2021
Change Notification Approval Date
March 18, 2022
Retention Due Date
July 25, 2025
Product Owner
Short Name
Lumenis Ltd.
Address
Yokneam Industrial Park, Hakidma Street 6, P.O.B. # 240, Yokneam 2069204, ISRAEL
Registrant
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #02-08, SINGAPORE 159557
Importer
Address
160 PAYA LEBAR ROAD, ORION @ PAYA LEBAR, #04-03, SINGAPORE 409022
Model Information
Model Name(s)
Stellar M22 System Stellar M22 Cart Stellar M22 Calibration Filter Stellar M22 Universal IPL 515 nm Expert Filter Stellar M22 Universal IPL 560 nm Expert Filter Stellar M22 Universal IPL 590 nm Expert Filter Stellar M22 Universal IPL 615 nm Expert Filter Stellar M22 Universal IPL 640 nm Expert Filter Stellar M22 Universal IPL 695 nm Expert Filter Stellar M22 Universal IPL 755 nm Expert Filter Stellar M22 SapphireCool LG 6mm kit  Stellar SapphireCool LG 15x35 kit  Stellar SapphireCool LG 8x15 kit  Stellar M22 Universal IPL Acne Filter (400-600 & 800-1200nm) Stellar M22 Universal IPL Vascular Filter (530-650 & 900-1200nm) Stellar M22  IPL Handpeice + Accessories Stellar M22 IPL Handpeice
Model Identifier(s)
GA-0006200 KT-20109290 KT-20112340 KT-20113600 KT-20113690 KT-20113710 KT-20113720 KT-20113790 KT-20113800 KT-20113830 KT-20115290 KT-20115410 KT-20115970 KT-20116590 KT-20116650 KT-2011940 SA-20106870