FDA.reportPublic FDA data

NA

Primary DI
01858028005083
Brand
NA
Company
ACQUIRE MED
Model
Q-200-RTR
Catalog number
097273
Published
2016-09-28
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
K050738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050738000FT FIBER OPTIC DELIVERY SYSTEMSFibertech GmbH2005-06-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01858028005083PackageGS15In Commercial Distribution
02858028005082PackageGS12In Commercial Distribution
00858028005084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01858028005083018580280050831858028005083
02858028005082028580280050822858028005082
00858028005084008580280050848580280050840858028005084

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, reusableA flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications [e.g., to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas), to heat/ablate mucosal tissue to treat vaginal laxity]. It is designed to direct laser light from a laser generator to the surgical site and may be available in a variety of configurations/technologies (using, e.g., fibreoptic materials, specialized mirrors). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061766352
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816901023440Acquire MedQ-940-RT0966572023-05-26
02816901023448Acquire MedQ-940-RT0966572023-05-26
00816901023808Acquire MedQ-272-RT0966552022-11-05
00816901023815Acquire MedQ-550-RT0967902022-11-05
00816901023174Acquire MedDB-3000965022022-05-27
00816901022986Acquire MedQ-550-RTR0972762021-06-14
02816901022984Acquire MedQ-550-RTR0972762021-06-14
00816901022818LEONI™Q-272-RT0966552021-06-01
00816901022825Acquire MedQ-365-RT0966562021-06-01
00816901022832Acquire MedQ-940-RT0966572021-06-01
00816901022849Acquire MedQ-550-RT0967902021-06-01
00816901022856Acquire MedQ-200-RT0972032021-06-01
02816901022816LEONI™Q-272-RT0966552021-06-01
02816901022823Acquire MedQ-365-RT0966562021-06-01
01816901022831Acquire MedQ-940-RT0966572021-06-01
02816901022847Acquire MedQ-550-RT0967902021-06-01
01816901022855Acquire MedQ-200-RT0972032021-06-01
00816901021453NAQ-272-RT(LEONI Barrel)0955502016-11-24
00816901021620NAQ-150-RT0955202017-03-02
00816901021637NAQ-200-RT0955222017-03-02

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Primary DI, Brand, Company table
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G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
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
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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
08059173390090Twain EvoQUANTA SYSTEM SPAGEX2018-12-14