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Quanta System Suprema Series Laser Systems - HSA Registration DE0509857

Access comprehensive regulatory information for Quanta System Suprema Series Laser 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 DE0509857 and owned by Quanta System S.P.A. The device was registered on September 30, 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.

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CLASS C
DE0509857
Quanta System Suprema Series Laser Systems
HSA Registration Number: DE0509857
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Product Description

SUPREMA Series medical devices are intended for use in medical specialties including plastic surgery, aesthetic medicine, dermatology and podiatry. SUPREMA Series medical devices are indicated for all skin types Fitzpatrick I-VI, including tanned skin. Devices are indicated for benign cutaneous lesions treatment (such as, but not limited to warts and actinic keratosis), inflammatory acne, acne vulgaris treatment, dermatological foot conditions (skin and nail) treatment: periungual and subungual warts, plantar warts, incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0509857
Registration Date
September 30, 2024
Retention Due Date
September 29, 2025
Product Owner
Short Name
Quanta System S.P.A
Address
Via Acquedotto, 109, 21017 Samarate (VA), ITALY
Registrant
Address
6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #04-06/07, SINGAPORE 787623
Importer
Address
6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #04-06/07, SINGAPORE 787623
Model Information
Model Name(s)
Twain 2940 Twain IPL Twain IPL Twain IPL Twain IPL Suprema VT Duetto Suprema Suprema VT+ Suprema 4V Suprema 4V MT Duetto MT Suprema Domino Suprema
Model Identifier(s)
OAM001729 OAM001815 OAM001816 OAM001817 OAM001828 PCMS00501 PCMS00502 PCMS00503 PCMS00504 PCMS00505 PCMS00506 PCMS00507