FDA.reportPublic FDA data

Bare Fiber R IR-Q 200

Primary DI
04058784000477
Brand
Bare Fiber R IR-Q 200
Company
Asclepion Laser Technologies GmbH
Model
2806
Device description
Reusable optical fiber for surgery
Published
2019-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

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
K133891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133891000MULTIPULSE TM+1470Asclepion Laser Technologies GmbH2015-01-30GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058784000477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058784000477040587840004774058784000477

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 intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4936417700309service@asclepion.com

Regulatory Flags#

DUNS number
332247852
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058784002655MultiPulse TFLJ19-8000-000J19-8000-0002025-11-27
04058784002693MultiPulse TFLJ19-8100-000J19-8100-0002025-11-27
04058784001542OMNIO10-0200-0002025-08-08
04058784000132TattooStar16412018-06-04
04058784000026QuardoStar PRO14902016-09-17
04058784000033QuadroStar PRO14912016-09-17
04058784000057QuardoStar PRO14932016-09-17
04058784002037MultiCut Blade 350839-3200-0002024-11-22
04058784002044MultiCut Blade 400839-3300-0002024-11-22
04058784002617DermablateM18-4200-0002024-11-11
04058784002624DermablateM18-4300-0002024-11-11
04058784000279MeDioStarM10-0200-0002020-03-27
04058784001986MultiPulse HoPLUSJ19-1191-000J19-1191-0002024-06-25
04058784000996MultiPulse HoPLUSJ19-1151-000J19-1151-0002019-12-03
04058784001009MultiPulse HoPLUSJ19-1161-000J19-1161-0002019-12-02
04058784000224MCL 31 Dermablate18232018-01-30
04058784000071MeDioStar NeXT PRO15922016-11-14
04058784000095SmoothPulse PRO159222016-09-17
04058784000101Pronto159212016-09-17
04058784000293Bare Fiber 2.1 20029542019-03-01

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Primary DI, Brand, Company table
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08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
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08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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