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GlobalMed Omnilux - HSA Registration DE0506677

Access comprehensive regulatory information for GlobalMed Omnilux in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506677 and owned by GlobalMed Technologies Co.. The device was registered on February 23, 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 B
DE0506677
GlobalMed Omnilux
HSA Registration Number: DE0506677
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Product Description

The Omnilux™ system is based on narrowband Light Emitting Diodes (LEDs). Clinicians can operate multiple treatment heads from a single operational base. Each treat­ment head delivers pure, optimized, narrowband light via a matrix of LEDs carefully positioned to deliver optimum light doses to the treatment area. The three Omnilux™ treatment heads emit light at specific, individual narrowband wavelengths to ensure optimal pho­tobiomodulation of target skin cells and maximum treat­ment efficacy in a wide range of dermatological conditions.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0506677
Registration Date
February 23, 2022
Retention Due Date
February 22, 2026
Product Owner
Short Name
GlobalMed Technologies Co.
Address
163 Camino Dorado suite B, Napa, California, 94558, UNITED STATES
Registrant
Address
27 TANNERY ROAD, SINGAPORE 347738
Importer
Address
27 TANNERY ROAD, SINGAPORE 347738
Model Information
Model Name(s)
Omnilux Blue Omnilux Plus Omnilux Revive
Model Identifier(s)
OMNILUX BLUE OMNILUX PLUS OMNILUX REVIVE