PL 400

GUDID 05713530000406

Ellipse A/S

Multi-modality skin surface treatment system
Primary Device ID05713530000406
NIH Device Record Keya7a5feae-a393-429b-975f-231f2d0966ec
Commercial Distribution StatusIn Commercial Distribution
Brand NamePL 400
Version Model Number9APP7749
Company DUNS305006145
Company NameEllipse A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105713530000406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-24
Device Publish Date2021-03-16

Devices Manufactured by Ellipse A/S

05713530000444 - Ellipse2021-10-19 Multi-modality skin surface treatment system: Intense Pulsed Light (IPL).
05713530000079 - HRD 6452021-03-24
05713530000253 - Nd:YAG Nordlys2021-03-24
05713530000260 - Nd:YAG MultiFlex2021-03-24
05713530000277 - Frax 15502021-03-24
05713530000291 - Frax 15502021-03-24
05713530000338 - HRL 6002021-03-24
05713530000345 - HRL 6002021-03-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.