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Alma Lasers Harmony XL PRO - HSA Registration DE0506744

Access comprehensive regulatory information for Alma Lasers Harmony XL PRO in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506744 and owned by Alma Lasers, Ltd. The device was registered on March 24, 2022.

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
DE0506744
Alma Lasers Harmony XL PRO
HSA Registration Number: DE0506744
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Product Description

The Harmony XL Pro Multi-Application Platform is intended for use in applications requiring ablation, vaporization, excision, incision, and photothermolysis of soft tissue in dermatology, general and plastic surgery. • Pro H. Power UV Module: psoriasis, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma - including vitiligo (acquired leukoderma) • Acne Module: treatment of moderate inflammatory acne vulgaris. • L.P. 1064 Pro, Cooled L.P. Pro Modules: treatment and clearance of Benign vascular lesions such as warts • Fungus L.P. Pro Module: is indicated for treatment and clearance of Benign vascular lesions such as warts, temporary increase of clear nail in patients with onychomycosis • NIR Body Module, NIR Face Modules: temporary relief of minor muscle pain and joint pain, temporary relief of minor joint pain associated with arthritis, muscle spasms, minor sprains and strains, minor muscular back pain.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0506744
Registration Date
March 24, 2022
Retention Due Date
March 23, 2026
Product Owner
Short Name
Alma Lasers, Ltd
Address
Halamish St Pob 3021, Industrial Park, Caesarea,, 38900,, ISRAEL
Registrant
Address
160 PAYA LEBAR ROAD, ORION @ PAYA LEBAR, #04-03, SINGAPORE 409022
Importer
Address
160 PAYA LEBAR ROAD, ORION @ PAYA LEBAR, #04-03, SINGAPORE 409022
Model Information
Model Name(s)
Harmony XL Pro System 220-230V (Black/Grey) LP Nd:YAG 1064 Cooled Fungus & LP Nd:YAG 1064 Cooled Acne 420 (6.4) Non Cooled 320 UVB High Power (6.4) Non Cooled NIR Face (6) NIR Body (18) Cover with New Foot Switch Pedal Fix
Model Identifier(s)
AAHP02110623GRH10001 AAHP08031501 AAHP08031505 AAHP19081001 AAIP24060801 AAIR10011202 AAIR11021000 AASP22081991