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Lumenis M22 skin surface treatment system - HSA Registration DE0006715

Access comprehensive regulatory information for Lumenis M22 skin surface 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 DE0006715 and owned by Lumenis Ltd. The device was registered on May 06, 2011.

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
DE0006715
Lumenis M22 skin surface treatment system
HSA Registration Number: DE0006715
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Product Description

The Lumenis M22 system has connection capability with the following available treatment modules, for multi-application treatment options. All modules are designed for aesthetic and dermatological skin procedure application, as follows: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with different filters) is indicated for warts and mild to moderate inflammatory acne (acne vulgaris). For the treatment of Evaporative Dry Eye Disease, also known as dry eye syndrome or lipid tear deficiency, due to Meibomian Gland Dysfunction. The Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm is indicated for coagulation and hemostasis of soft tissue. The ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for use in dermatological procedures requiring coagulation of soft tissue.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0006715
Registration Date
May 06, 2011
Change Notification Approval Date
March 18, 2022
Retention Due Date
May 05, 2026
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)
Univeral IPL eyewear - OP5 Univeral IPL eyewear -OP 3 Univeral IPL eyewear - Opaque eye protectors Nd: YAG safety eyewear OD7 Nd: YAG safety eyewear OD7 IPL coupling gel 0.25L IPL coupling gel 1L M22 ResurFX SapphireCool Light Guide Tip ResurFX Precision Tip M22 Q-Switch Lens Assembly & 6 mm Metal Treatment Tip KIT Q-Switch Nd:YAG Metal Treatment Tip 6 mm (Box of 1) Q-Switch Nd:YAG Metal Treatment Tip 5 mm (Box of 1) Q-Switch Nd:YAG Metal Treatment Tip 3.5 mm (Box of 1) Q-Switch Nd:YAG Metal Treatment Tip 2.5 mm (Box of 1) Q-Switch Nd:YAG Metal Treatment Tip 2 mm (Box of 1) Q-Switch Lens Assembly (Box of 1) Q-Switch Nd:YAG Metal Treatment Tip 4 mm (Box of 1) Q-Switch Nd:YAG Metal Treatment Tip 8 mm (Box of 1) Multi-Spot Nd:YAG SapphireCool Light Guide โ€“ 1.5 mm Universal IPL Vascular filter (530-650 & 900-1200 nm) Universal IPL SapphireCool Light Guide โ€“ 6 mm Universal IPL 515 nm Expert filter Universal IPL 560 nm Expert filter Universal IPL 590 nm Expert filter Universal IPL 615 nm Expert filter Universal IPL 640 nm Expert filter Universal IPL 695 nm Expert filter Universal IPL 755 nm Expert filter Universal IPL Acne filter (400-600 & 800-1200 nm) M22 Universal IPL Filter Kit โ€“ 6 Filters (content: 515, 560, 590, 615, 640, 695nm filters) Multi-spot Nd:YAG SapphireCool Light Guide set (content: 2x4 mm and 6 mm) Q-Switched Nd:YAG Disposable Tips Spot Size 2.5 mm (Box of 30) Q-Switched Nd:YAG Disposable Tips Spot Size 3.5 mm (Box of 30) Q-Switched Nd:YAG Disposable Tips Spot Size 2 mm (Box of 30) Q-Switched Nd:YAG Disposable Tips Spot Size 2 mm (Box of 30) Universal IPL SapphireCool Light Guide set (content: 15x35 mm and 8x15 mm) Universal IPL 515 nm Expert filter (set of 4) Universal IPL 560 nm Expert filter (set of 4) Universal IPL 590 nm Expert filter (set of 4) Universal IPL 615 nm Expert filter (set of 4) Universal IPL 640 nm Expert filter (set of 4) Universal IPL 695 nm Expert filter (set of 4) Universal IPL 755 nm Expert filter (set of 4) Multi-spot Nd:YAG SapphireCool Light Guide โ€“ 2 x 4 mm Multi-spot Nd:YAG SapphireCool Light Guide โ€“ 6 mm Multi-spot Nd:YAG SapphireCool Light Guide โ€“ 9 mm Universal IPL SapphireCool lightguide 15 x 35mm Universal IPL SapphireCool lightguide 8 x 15mm Q-Switched Nd:YAG treatment head Universal IPL Treatment Head M22 ResurFX Handpiece Multi-Spot Nd:YAG treatment head M22 Universal IPL treatment head ResurFX Handpiece replacement M22 Multi-Spot Nd:YAG Upgrade Kit M22 ResurFX Module Upgrade Kit M22 Q-Switched Nd:YAG Upgrade Kit
Model Identifier(s)
AX0000010 AX0000011 AX0000025 AX0000066 AX0000067 AX1009018 AX1009019 GA-0005200 (Includes KT-1048740) KT-10000965 KT-10000975 KT-10024830 KT-10024840 KT-10024850 KT-10024860 KT-10024870 KT-10024880 KT-10024890 KT-1006452 KT-1006456 KT-1006457 KT-1007279 KT-1007656 KT-1014900 KT-1014911 KT-1014920 KT-1014930 KT-1014940 KT-1014951 KT-1014961 KT-1014971 KT1048740 KT1048770 KT3750030 KT3750040 KT3750050 KT3750060 KT6500071 KT6774001 KT6775002 KT6776001 KT6777001 KT6778001 KT6779002 KT6780002 KT6794000 KT6795000 KT6796000 KT6797001 KT6798000 SA-1020221 SA-102635012 SA-1146410 SA1020220 SA1026350 SPSA-1146410 UG-0005100 UG-1000324 UG-1000400