Catalog Number

AAHP08031503WR0002

Brand Name

Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / Pro

Version/Model Number

02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K072564

Product Code

FTC

Product Code Name

Light, Ultraviolet, Dermatological

Public Device Record Key

2f528dfe-c08c-4c49-9066-2ca581c2c1f7

Public Version Date

July 02, 2020

Public Version Number

1

DI Record Publish Date

June 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-