FDA.reportPublic FDA data

Adler MicroMed Laster Surgery Fiber

Primary DI
00850348007014
Brand
Adler MicroMed Laster Surgery Fiber
Company
ADLER MICROMED, INC.
Model
SFCS000101
Catalog number
SFCS000101
Device description
Adler MicroMed Laser Surgery Fiber 2.5 NC 400 RSCF 1.3
Published
2016-10-17
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
K152417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152417000Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.2015-12-01GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850348007076PackageGS15In Commercial Distribution
00850348007137PackageGS110In Commercial Distribution
00850348007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850348007076008503480070768503480070760850348007076
00850348007137008503480071378503480071370850348007137
00850348007014008503480070148503480070140850348007014

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

Regulatory Flags#

DUNS number
080298464
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850348007359Adler Hemorrhoid LigatorAdler Hemorrhoid LigatorAL90002024-02-24
00850348007403Adler MicroMed Laser Surgery Fiber 6350002356350002352024-02-12
00850348007434Adler MicroMed Laser Surgery Fiber 6310002886310002882024-02-12
00850348007465Adler MicroMed Laser Surgery Fiber 6310003026310003022024-02-12
00850348007496Adler MicroMed Laser Surgery Fiber 6310003046310003042024-02-12
00850348007526Adler MicroMed Laser Surgery Fiber 6310002966310002962024-02-12
00850348007410Adler MicroMed Laser Surgery Fiber 6350002356350002352024-02-12
00850348007441Adler MicroMed Laser Surgery Fiber 6310002886310002882024-02-12
00850348007472Adler MicroMed Laser Surgery Fiber 6310003026310003022024-02-12
00850348007502Adler MicroMed Laser Surgery Fiber 6310003046310003042024-02-12
00850348007533Adler MicroMed Laser Surgery Fiber 6310002966310002962024-02-12
00850348007182Adler MircroMed Laser Surgery FiberBFCS000288BFCS0002882018-07-09
00850348007243Adler MicroMed Laser Surgery FiberBFCS000302BFCS0003022018-11-13
00850348007007Adler MicroMed Laser Surgery FiberSFCS000099SFCS0000992016-10-17
00850348007304Adler MicroMed Laser Surgery FiberSFCS0002352018-12-05
00850348007373Adler MicroMed Laser Surgery Fiber 6360000996360000992023-11-24
00850348007380Adler MicroMed Laser Surgery Fiber 6360000996360000992023-11-24
00850348007335Hemorrhoid LigatorAL8000AL80002019-10-01
00850348007212Adler MicroMed Laser Surgery FiberBFCS000296BFCS0002962018-07-11
00850348007021Adler MicroMed Laser Surgery FiberSFCS000102SFCS0001022016-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
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
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single 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