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Palomar Icon™ Aesthetic System - HSA Registration DE0014932

Access comprehensive regulatory information for Palomar Icon™ Aesthetic 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 DE0014932 and owned by Palomar Medical Technologies, Inc. The device was registered on March 12, 2014.

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
DE0014932
Palomar Icon™ Aesthetic System
HSA Registration Number: DE0014932
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Product Description

The Palomar Icon™ Aesthetic System is intended for various aesthetic, cosmetic and dermatological related indications by different IPL and laser handpieces. 2940 Ablative Handpiece is for dermatological procedures requiring coagulation, vaporization, resurfacing, and ablation and/or cutting of soft tissue. 2940 Ablative Fractional Handpiece is for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. 1540 Fractional Handpiece is for coagulation of soft tissue, skin resurfacing procedures. MaxIR Handpiece is for photocoagulation of soft tissue in dermatologic applications. 1064+ handpiece is for removal of unwanted hair; treatment of benign pigmented lesions, vascular lesions, coagulation and hemostasis of soft tissue. Max Series IPL Handpieces are for the treatment of inflammatory acne and benign pigmented epidermal and cutaneous lesions, removal of unwanted hair. Skintel Reader is an objective skin melanin measurement tool.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0014932
Registration Date
March 12, 2014
Retention Due Date
March 11, 2026
Product Owner
Short Name
Palomar
Address
15 Network Drive, Burlington, MA 01803, UNITED STATES
Registrant
Address
27 TANNERY ROAD, SINGAPORE 347738
Importer
Address
27 TANNERY ROAD, SINGAPORE 347738
Model Information
Model Name(s)
Icon Control Module Heat Exchanger Module Icon Cooling Module System Dolly Rear Cosmetic Assembly ICON Hanger Boom Assy. Max G Spot Adaptor (5/pk) Skintel 1064+ HP Icon 1440 Fractional HP - Icon 1540 Fractional HP - Icon 2940 Laser HP - Icon XF Tip Max G - Icon MAX IR Max R - Icon Max Rs - Icon Max Y - Icon Max Ys - Icon Focal Guide (6 x 6 mm) Focal Guide (10 x 10 mm) Gliding Focal Guide (10 x 10 mm) Blue Optic Green Optic Groove Optic Purple Optic (2mm) 10mm Artisan/Icon Lens 15mm Artisan/Icon Lens XD Artisan/Icon Lens Icon Energy Icon Artisan Package Bundle Icon Artisan Package Energize Bundle Icon Full Access Bundle Icon Full Access Energize Bundle Icon OPL ONLY Bundle Icon OPL ONLY Energize Bundle Icon Stand Alone Bundle Icon Stand Alone Energize Bundle
Model Identifier(s)
2520-0003 2520-0004 2520-0005 2520-0006 2520-0021 2520-0032 2520-0035 2520-0038 2520A-1064P 2520A-1440 2520A-1540 2520A-2940 2520A-4000 2520A-G046 2520A-IR36 2520A-R026 2520A-RS26 2520A-Y026 2520A-YS06 5520-2028 5520-2030 5520-2031 5520-2035 5520-2042 5520-2047 5520-2048 8520A-4001 8520A-4014 8520A-4406 9999-1500EP 9999-2500AP 9999-2500APE 9999-2500FA 9999-2500FAE 9999-2500IO 9999-2500IOE 9999-2500SA 9999-2500SAE