FDA.reportPublic FDA data

EASYRET

Primary DI
03700542625927
Brand
EASYRET
Company
QUANTEL MEDICAL
Model
EASYRET
Device description
The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator device intended for the treatment of retinal diseases.
Published
2021-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170067000EasyretQuantel Medical2017-07-25HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700542625927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700542625927037005426259273700542625927

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser system, photocoagulation/photostimulationAn electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for: 1) ocular photocoagulation-based procedures (e.g., coagulate abnormal vascular tissue in the retina); and/or 2) dosimetery-controlled photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration; it might additionally be intended for iridectomy. It may include a built-in slit lamp and a dosimetry sensor, however, it does not include femtosecond pulsing or fundus imaging technology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33(0)473745745contact@quantel-medical.fr

Regulatory Flags#

DUNS number
738574953
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700542625958CAPSULOCAPSULO2025-03-25
03700542626009POCKET IIIPOCKET III2025-03-25
03700542625316SUPRA 577YSUPRA 577Y2016-09-23
03700542625941AXIALISAXIALIS2022-01-05
03700542625569VITRA 2 VITRA 2 2021-12-29
03700542625613VITRA 810VITRA 8102021-12-29
03700542625132VITRAVITRA2016-09-23
03700542625286SUPRASUPRA2016-09-23
03700542625415VITRA MULTISPOTVMS2016-09-23
03700542625484EASYRETEASYRET2017-09-11
03700542625224532nm Heine Omega IO with integrated adaptorIOH8105322016-09-23
03700542625231532nm adaptor for Keeler Vantage Plus IO (100µ)810532IOVPST2016-09-23
03700542625248Keeler Vantage Plus IOLAFVP22016-12-07
03700542625392577nm Heine Omega 500 IO with integrated adaptorIOH5772016-09-23
03700542625408577nm adaptor for Keeler Vantage Plus IO (100µ)577IOV1002016-09-23
03700542625521ABSOLUABSOLU2019-07-09
03700542625002AVISO (S)AVISO (S)2016-09-23
03700542625057B Probe 10MHz AVISOB1 AVISO2016-09-23
03700542625064B Probe 20MHz AVISOB-HF AVISO2016-09-23
03700542625118A Standardized ProbeStd-A2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
08717872014142Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014173Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014203Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014968Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014975Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014982Directional Laser Probe with DORC connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031781EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031798EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031897Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
1081748902371320ga Curved Illuminated Laser Probe, 19ga Needle Illumination, IridexKATALYST SURGICAL LLCHQF2020-11-28
1081748902372020ga Curved Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-28
1081748902373720ga Curved Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-28
1081748902374420ga Curved Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-28
1081748902375120ga Curved Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-28
1081748902376823ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902377523ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902378223ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902379923ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902380523ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902381225ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902382925ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902383625ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902384325ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902385025ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-27
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27