Femilift HP & Camera - ALMA LASERS LTD.

Duns Number:532283264

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More Product Details

Catalog Number

AACO31121501

Brand Name

Femilift HP & Camera

Version/Model Number

1

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

K103501

Product Code Details

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Device Record Status

Public Device Record Key

23c2be44-dbe6-4fdb-b460-42a418b4e8b0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALMA LASERS LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 167