FDA.reportPublic FDA data

NA

Primary DI
M735B5677041
Brand
NA
Company
OPHTHALMED LLC
Model
B567704
Published
2022-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K050807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K05080700020G SMA LASER FIBER, MODEL LF100Ophthalmed, LLC2005-09-21HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M735B5677045PackageHIBCC10In Commercial Distribution
M735B5677041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge25Gauge

Contacts#

Phone, Email table
PhoneEmail
7707776613info@ophthalmed.com

Regulatory Flags#

DUNS number
791553436
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M735A5026001NAA5026002022-09-22
M735A5027001NAA5027002022-09-22
M735A5036001NAA5036002022-09-22
M735A5037001NAA5037002022-09-22
M735A5076001NAA5076002022-09-22
M735A5077001NAA5077002022-09-22
M735A5086001NAA5086002022-09-22
M735A5087001NAA5087002022-09-22
M735A5096001NAA5096002022-09-22
M735A5097001NAA5097002022-09-22
M735A50A6001NAA50A6002022-09-22
M735A50A7001NAA50A7002022-09-22
M735A50B6001NAA50B6002022-09-22
M735A50B7001NAA50B7002022-09-22
M735A5226001NAA5226002022-09-22
M735A5227001NAA5227002022-09-22
M735A5236001NAA5236002022-09-22
M735A5237001NAA5237002022-09-22
M735A5246001NAA5246002022-09-22
M735A5247001NAA5247002022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-09-27
08717872034652EVA Vitrectomy Pack VGPC Input 20GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034683EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034690EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034706EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872032672EVA Custom TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032702EVA Custom TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032122EVA Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032139EVA Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032146EVA Vitrectomy Pack Gravity Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032153EVA Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032160EVA TDC Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032177EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032184EVA TDC Vitrectomy Pack Gravity Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032191EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032221EVA TDC Vitrectomy Pack Gravity Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032238EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872034430EVA NEXUS™, Phaco vitrectomy system including laser with DORC connectorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-08-01
08717872034447EVA NEXUS™, Phaco vitrectomy system including laser with SMA connectorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-08-01
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