FDA.reportPublic FDA data

ProFlex™

Primary DI
00816959021641
Brand
ProFlex™
Company
INNOVAQUARTZ LLC
Model
200 Reusable Laser Lithotripsy Fiber var. Trimedyn
Catalog number
R-LLF200TG-T-USL
Published
2020-08-17
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
K180140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180140000ProFlex Laser FibersInnovaquartz, LLC2018-04-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816959021641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816959021641008169590216418169590216410816959021641

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
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
844-776-3539info@proflexfibers.com

Regulatory Flags#

DUNS number
079295103
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816959021924Dornier Thulio Performance Fiber200 micron Ball Tip Single UseK20163672026-04-21
00816959021931Dornier Thulio Performance Fiber270um Ball Tip Single UseK20163682026-04-21
00816959021948MegaJOULE LDD™HaloFiber Radial Delivery Device 660HFRDD6602026-04-21
00816959021955MegaJOULE LDD™DragonFiber Lateral Delivery Device 660DFLDD6602026-04-21
00816959021627MegaJOULE LDD™MegaJOULE Lateral Delivery Device 660MJLDD6602021-07-22
00816959021870Dornier Thulio Performance Fiber200um Single-Use FiberK20163602025-04-24
00816959021887Dornier Thulio Performance Fiber200um Reusable FiberK20163692025-04-24
10816959021877Dornier Thulio Performance Fiber200um Single-Use FiberK20163602025-04-24
10816959021884Dornier Thulio Performance Fiber200um Reusable FiberK20163692025-04-24
00816959021672ProFlex™ 273 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF273TG-T-USL2020-08-18
00816959021696ProFlex™365 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF365-T-USL2020-08-18
00816959021719ProFlex™550 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF550-T-USL2020-08-18
00816959021733ProFlex™910 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF910-T-USL, R-LLF1000-T-USL2020-08-18
00816959021634ProFlex™ 200 Reusable Laser Lithotripsy FiberR-LLF200LT-USL2020-08-17
00816959021658ProFlex™200 Reusable Laser Lithotripsy FiberR-LLF200TG-USL2020-08-17
00816959021665ProFlex™273 Reusable Laser Lithotripsy FiberR-LLF273LT-USL2020-08-17
00816959021689ProFlex™ 273 Reusable Laser Lithotripsy FiberR-LLF273TG-USL2020-08-17
00816959021702ProFlex™365 Reusable Laser Lithotripsy FiberR-LLF365-USL2020-08-17
00816959021726ProFlex™550 Reusable Laser Lithotripsy FiberR-LLF550-USL2020-08-17
00816959021740ProFlex™910 Reusable Laser Lithotripsy FiberR-LLF910-USL, R-LLF1000-USL2020-08-17

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