Singapore HSA registration DE0018073
Synergetics Laser Probes
Singapore·CLASS B·Synergetics Inc.·Registered April 29, 2016Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0018073
- Registration Date
- April 29, 2016
- Change Notification Approval Date
- February 10, 2023
- Retention Due Date
- April 28, 2026
Product description
Fibreoptic laser delivery system designed to transmit laser light to a selected focal area. It is intended as a single use device and is provided sterile. The device provides a means of delivering endophotocoagulation and/or illumination during vitrectomy surgery. Indications include, but are not limited to treatment of proliferative diabetic retinopathy, proliferative vitreoretinopathy, retinal detachments, retinal tears, retinal holes, etc. This device transmits laser energy to target tissue, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
Product Owner
- Name
- Synergetics Inc.
- Short Name
- Synergetics Inc.
- Address
- 3845 Corporate Center Drive,, O'Fallon, Missouri,, 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)
- Curved laser probe Large Curved Laser Probe Straight Laser Probe 23ga Straight Laser Probe Stiff 25ga Straight Laser Probe Maxillum Focused Laser Probe Curved laser probe TruCurve Laser Probe for 23ga Surgery TruCurve Laser Probes for 25ga Surgery TruCurve Laser Probe for 27ga Surgery Flexible Tapered (23ga) Laser Probe Flexible Tapered (25ga) Laser Probe Directional Laser Probe 23ga Directional Laser Probe 23ga Extendable Directional Laser Probe 23ga Directional Laser Probe, Lumenis 25ga Directional Laser Probe 25ga Extendable Directional Laser Probe 25ga Directional Laser Probe, Lumenis 27ga Directional Laser Probe Extendable Directional Laser Probe 20ga Directional II Laser Probe 23ga Directional II Laser Probe 25ga Directional II Laser Probe 27ga Directional II Laser Probe 23ga Inverted Extendable Directional Laser Probe 25ga Inverted Extendable Directional Laser Probe Inverted Extendable Directional Laser Probe 23ga Directional Illuminated Laser Probe 25ga Directional Illuminated Laser Probe 23ga Illuminated Directional II Laser Probe 25ga Illuminated Directional II Laser Probe 23ga Straight Fixed Extended Illuminated Laser Probe 25ga Straight Fixed Extended Illuminated Laser Probe Curved Fixed Extended Wide Field Illuminated Laser Probe 23ga Curved Fixed Extended Illuminated Laser Probe 25ga Curved Fixed Extended Illuminated Laser Probe Curved Fixed Extended Illuminated Laser Probe 23ga Flexible Tapered Illuminated Laser Probe 25ga Flexible Tapered Illuminated Laser Probe
- Model Identifier(s)
- 55.08 55.12 55.21 55.21.23 55.21.25S 55.22-3 55.23 55.23.23 55.23.25 55.23.27 55.25.23 55.25.25 55.26 55.26.23 55.26.23E 55.26.23L 55.26.25 55.26.25E 55.26.25L 55.26.27 55.26E 55.27 55.27.23 55.27.25 55.27.27 55.36.23E 55.36.25E 55.36E 55.47.23P 55.47.25P 55.48.23P 55.48.25P 55.62.23P 55.62.25P 55.63P 55.69.23P 55.69.25P 55.69P 55.70.23P 55.70.25P
About this record
Access comprehensive regulatory information for Synergetics Laser 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 DE0018073 and owned by Synergetics Inc.. The device was registered on April 29, 2016.
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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