FDA.reportPublic FDA data

Re-Usable surgical optical fiber

Primary DI
08051272101119
Brand
Re-Usable surgical optical fiber
Company
HYPER PHOTONICS SRL
Model
BO000014
Device description
Re-Usable 10x 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
OTC
false
Sterile
true
Single use
false

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
08051272101102PackageGS15In Commercial Distribution
08051272101119PackageGS12In Commercial Distribution
08051272101096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051272101102080512721011028051272101102
08051272101119080512721011198051272101119
08051272101096080512721010968051272101096

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA 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. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
430142152
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
08051272101126Single use surgical optical fiberBO0000152018-02-16
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
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
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06970745912934ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912996ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
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04053002150514CORONA 360 Fused 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
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00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
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06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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