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Fotona Spectro Laser System - HSA Registration DE0017694

Access comprehensive regulatory information for Fotona Spectro 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 DE0017694 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
DE0017694
Fotona Spectro Laser System
HSA Registration Number: DE0017694
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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. The Nd:YAG laser is indicated for use in Dermatology, Podiatry, Endovenous Laser Therapy, Laser-Assisted Lipolysis, and General Surgery.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0017694
Registration Date
December 04, 2015
Change Notification Approval Date
January 31, 2018
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)
Fiber scribing tool 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 FIBER MOCK SMA 905 HP R08-Ti HP R09-2G HP R09-3T HP R11 HP R34 R33 handpiece, complete package R34 Handpiece, complete package Catheter, 300-600 um R33/R34 fiber protective tube R34 handpiece assembly R33 D2MM OPTICS ASSEMBLY R33 D3MM OPTICS ASSEMBLY R33 D4MM OPTICS ASSEMBLY R33 D5MM OPTICS ASSEMBLY R33 D6MM OPTICS ASSEMBLY R33 D7MM OPTICS ASSEMBLY R33 D8MM OPTICS ASSEMBLY R33 D9MM OPTICS ASSEMBLY R33 D10MM OPTICS ASSEMBLY R33/34 COLD AIR ADAPTER ASSEMBLY R33/R34 PROTECTIVE WINDOW R33/34 spacer (60 mm) R34 protective window R34 D 15 mm optics assembly R34 D 20 mm optics assembly R33/R34 COLD AIR ADAPTER FOR ZIMMER TUBE HP R33 PACKAGE 1 CE ENG PS01 spacer, D 12 mm PS01 spacer, D 10 mm R27 Body Canula, 3x120 welded Canula, 3x200 welded Canula, 3x300 welded 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 Fiber stripping tool 300/1000 um R04-TI handpiece, complete package PS02 handpiece, complete package FOOTSWITCH ASSEMBLY, WIRELESS V1 R04-TI handpiece assembly R04 PSA handpiece assembly Male luer lock adapter R04 PSV handpiece assembly PS01, complete package HP PS02 HP R04-TI HP PS01 PS01 spacer, D 7 mm PS03 handpiece assembly Fiber stopper Extender HP PS03 Adapter, socket-socket Fiber tightener, 600 um-engraved HP R27 600 um Surgical set III Fiber stripping tool, 600 um FIBER BEAM DELIVERY 1, 940, 1.7M ASSEMBLY FIBER BEAM DELIVERY 1, 940, 2 M ASSEMBLY FIBER BEAM DELIVERY 1 1,7M –ASS 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 Female luer lock adapter FS-01, complete package HP FS-01 Conical tip HP R27-C complete package R27-C R11 / PS03 protective window R17 protective window R27-C-body R09-3T handpiece assembly Fiber beam delivery, 600um EVLA 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 SP SPECTRO M02I4AF/3 SP SPECTRO TS, M021-4AF/3 CE ENG G-SET SPECULUM SCLEAR (disposable) G-SET EXPERT CE ENG 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)
Model Identifier(s)
40002 49894 58619 58642 59525 60582 60583 61151 64341 68276 68356 68704 68706 68708 68717 69116 70835 70837 70838 70945 71069 71328 71329 72021 72911 73273 73274 73275 73276 73277 73278 73279 73280 73281 73282 73285 73575 74039 75504 75505 75506 75918 80862 81201 81578 82315 82436 82437 82438 82604 82605 82606 82607 82608 82611 82637 82638 82665 82670 82671 83012 83033 83034 83244 83246 83247 83653 83678 83766 83800 83977 84158 85677 85700 86017 86377 86837 86838 86849 88618 88920 88923 88925 88928 88930 89157 89174 89258 89416 89457 89616 89623 89672 89957 90038 90076 90109 90974 92220 92386 92899 92921 93686 93784 93920 93921 94446 94713 96764 97193 97194 97195 97196