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Fotona Dynamis Laser System - HSA Registration DE0017695

Access comprehensive regulatory information for Fotona Dynamis Laser 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 DE0017695 and owned by Fotona d.o.o. The device was registered on December 04, 2015.

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
DE0017695
Fotona Dynamis Laser System
HSA Registration Number: DE0017695
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Product Description

The Er:YAG laser is indicated for use in Dermatology and Plastic Surgery, ENT Surgery, Oral/Maxillofacial, Ophthalmology, General Surgery, Podiatry, Gynecology, Genitourinary, Intra-oral soft tissue incision, excision, ablation, coagulation, Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0017695
Registration Date
December 04, 2015
Change Notification Approval Date
May 15, 2024
Retention Due Date
December 03, 2025
Product Owner
Short Name
Fotona d.o.o
Address
Stegne 7, 1000 Ljubljana, SLOVENIA
Registrant
Address
140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #06-03, SINGAPORE 409015
Importer
Address
140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #06-03, SINGAPORE 409015
Model Information
Model Name(s)
PS03X,handpiece Pen 1.0 D,handpiece Er:YAG handpiece sapphire window R11 handpiece assembly R11 handpiece spacer Cutting spacer R09-2G handpiece assembly R09-G applicator Hair transplant spacer SAFETY GOGGLES ER/ND, UNIVET R08-TI handpiece assembly FOOTSWITCH ASSEMBLY R09-3T handpiece, complete package R09-2G handpiece, complete package R11 handpiece, complete package R08-TI, complete package HP R08-Ti HP R09-2G HP R09-3T HP R11 PS01 spacer, D 12 mm PS01 spacer, D 10 mm R04 TI / PS02 spacer, D 3 mm R04 TI / PS02 spacer, D 5 mm R04 TI / PS02 spacer, D 7 mm R04 TI / PS02 spacer, D 10 mm R04 TI / PS02 spacer, D 12 mm R04-TI handpiece, complete package PS02 handpiece, complete package FOOTSWITCH ASSEMBLY, WIRELESS V1 R04-TI handpiece assembly R04 PSA handpiece assembly R04 PSV handpiece assembly PS01, complete package HP PS02 HP R04-Ti HP PS01 PS01 spacer, D 7 mm PS03 handpiece assembly HP PS03 FS-01, fractional handpiece assembly G-SET SPECULUM STANDARD GA MIRROR (consumable spare part) GA ADAPTER ASSEMBLY GC ADAPTER ASSEMBLY GC MIRROR (consumable spare part) G-SET FS-01 protective window FS-01, complete package HP FS-01 R11 / PS03 protective window R17 protective window R09-3T handpiece assembly G-SET SPECULUM SLIM G-SET COMPLETE CE ENG G-SET SPECULUM MCLEAR (disposable) ARTICULATED ARM DS TS G-SET SLIM CE ENG G-SET SPECULUM SLIM LONG XS DYNAMIS M002-2A XS DYNAMIS M002-2A CE ENG G-SET SPECULUM SCLEAR (disposable) G-SET EXPERT CE ENG Speculum GClear25 R Speculum GClear30 R G-RUNNER SET SMALL SPECULUM GCLEAR25 (PACK OF 10) LARGE SPECULUM GCLEAR30 (PACK OF 10) SMALL SPECULUM GCLEAR25 (PACK OF 42) LARGE SPECULUM GCLEAR30 (PACK OF 42) R09-2Gu,handpiece
Model Identifier(s)
100267 111408 49894 58619 58642 59525 60582 60583 61151 64341 68276 68356 68704 68706 68708 68717 70835 70837 70838 70945 81201 81578 82604 82605 82606 82607 82608 82637 82638 82665 82670 82671 83033 83034 83244 83246 83247 83653 83678 83977 88618 88920 88923 88925 88928 88930 89157 89174 89416 89457 89957 90038 90109 92220 92386 92899 92921 93686 93784 93917 93918 94446 94713 96266 96267 96764 97193 97194 97195 97196 97875