EASYRET - The laser (577 nm Fiber Techology Laser - QUANTEL MEDICAL

Duns Number:738574953

Device Description: The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Haag Streit mode) is a photocoagulator device intended for the treatment of retinal diseases.

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More Product Details

Catalog Number

-

Brand Name

EASYRET

Version/Model Number

EASYRET

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170067

Product Code Details

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Device Record Status

Public Device Record Key

9f4e38e9-129e-4e28-9a8d-6bdd1275ec32

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUANTEL MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 55