FDA.reportPublic FDA data

NA

Primary DI
00816901021637
Brand
NA
Company
ACQUIRE MED
Model
Q-200-RT
Catalog number
095522
Published
2017-03-02
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
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
01816901021636PackageGS15In Commercial Distribution
02816901021635PackageGS12In Commercial Distribution
00816901021637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816901021636018169010216361816901021636
02816901021635028169010216352816901021635
00816901021637008169010216378169010216370816901021637

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, single-useA flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.

Regulatory Flags#

DUNS number
061766352
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
00858028005008NAQ-150-RT0972022016-09-28

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G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
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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
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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