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Synergetics Stellaris Illumination Probes - HSA Registration DE0506832

Access comprehensive regulatory information for Synergetics Stellaris Illumination Probes in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506832 and owned by Synergetics Inc.. The device was registered on April 28, 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
DE0506832
Synergetics Stellaris Illumination Probes
HSA Registration Number: DE0506832
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Product Description

This device provides a means of delivering illumination during vitrectomy surgery. Indications include, but are not limited to treatment of vitreous hemorrhage, proliferative diabetic retinopathy, proliferative vitreoretinopathy, retinal detachments, retinal tears, retinal holes, etc. Indications for illuminated picks include, but are not limited to, epiretinal membrane removal, macular hole surgery, proliferative vitreoretinopathy, etc. This device transmits illumination to the intraocular space, thereby allowing the surgeon to view ocular tissues by means of a microscope and lens system. Spot size can be varied by altering the distance between this tissue and the probe tip.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0506832
Registration Date
April 28, 2022
Retention Due Date
April 27, 2026
Product Owner
Short Name
Synergetics Inc.
Address
3845 Corporate Centre Drive, O'Fallon, Missouri, 63368, UNITED STATES
Registrant
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Importer
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Model Information
Model Name(s)
25ga Vivid Chandelier - Stellaris PC 27ga Vivid Chandelier - Stellaris PC 20ga Diffuse Wide-Field Endoilluminator - Stellaris 20ga Stellaris PC Mid-Field Endoilluminator 23ga Diffuse Wide-Field Endoilluminator - Stellaris 23ga Stellaris PC Mid-Field Endoilluminator 25ga Stellaris PC Diffuse Wide-Field Endoilluminator 25ga Stellaris PC Mid-Field Endoilluminator 27ga Stellaris PC Mid-Field Endoilluminator
Model Identifier(s)
BL5235S BL5237S BL5820D BL5820M BL5823D BL5823M BL5825D BL5825M BL5827M