FDA.reportPublic FDA data

NA

Primary DI
M735A2140001
Brand
NA
Company
OPHTHALMED LLC
Model
A214000 
Published
2016-09-24
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

Contact Domains#

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
K021696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K02169600020G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25Ophthalmed, LLC2002-08-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M735A2140005PackageHIBCC10In Commercial Distribution
M735A2140001PrimaryHIBCC0

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 Gauge20Gauge

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
M735B5677041NAB5677042022-09-26
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

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