FDA.reportPublic FDA data

Single use surgical optical fiber

Primary DI
08051272101126
Brand
Single use surgical optical fiber
Company
HYPER PHOTONICS SRL
Model
BO000015
Device description
365um surgical optical fiber
Published
2018-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163449000HyPHo Laser SystemHyper Photonics Srl2017-06-23GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051272101133PackageGS15In Commercial Distribution
08051272101140PackageGS12In Commercial Distribution
08051272101126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051272101133080512721011338051272101133
08051272101140080512721011408051272101140
08051272101126080512721011268051272101126

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-useA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device.

Regulatory Flags#

DUNS number
430142152
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051272101034Re-Usable surgical optical fiberBO0000122018-02-16
08051272101065Single use surgical optical fiberBO0000132018-02-16
08051272101096Re-Usable surgical optical fiberBO0000142018-02-16
08051272101157Re-Usable surgical optical fiberBO0000162018-02-16
08051272101188Single use surgical optical fiberBO0000172018-02-16
08051272101249Single use surgical optical fiberBO0000192018-02-16
08051272101218Re-Usable surgical optical fiberBO0000182018-02-16
08051272101058Re-Usable surgical optical fiberBO0000122018-02-16
08051272101089Single use surgical optical fiberBO0000132018-02-16
08051272101119Re-Usable surgical optical fiberBO0000142018-02-16
08051272101140Single use surgical optical fiberBO0000152018-02-16
08051272101171Re-Usable surgical optical fiberBO0000162018-02-16
08051272101195Single use surgical optical fiberBO0000172018-02-16
08051272101263Single use surgical optical fiberBO0000192018-02-16
08051272100310HYPHOHH0680002018-02-16
08051272100334O35HH0660002018-05-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14