EPY-50 EPY-50

GUDID 00860002307039

Pulsed Nd:YAG Laser

DDC TECHNOLOGIES, INC.

Dermatological solid-state laser system
Primary Device ID00860002307039
NIH Device Record Key25779a3c-d532-4302-af96-76bde5dd4b26
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPY-50
Version Model NumberEPY-50
Catalog NumberEPY-50
Company DUNS128532707
Company NameDDC TECHNOLOGIES, INC.
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone516-5941533
Emailsales@ddctech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002307039 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2019-12-09

Devices Manufactured by DDC TECHNOLOGIES, INC.

00860002307008 - Polylase2020-02-06 Dual Output Pulsed Alexandrite and Nd:YAG Laser
00860002307022 - AL-402020-02-06 Pulsed Alexandrite Laser
00860002307039 - EPY-502020-02-06Pulsed Nd:YAG Laser
00860002307039 - EPY-502020-02-06 Pulsed Nd:YAG Laser
00860002307046 - Polylase2020-02-06 Dual Output Pulsed Alexandrite and Nd:YAG Laser
90860002307018 - Polylase2020-02-06 Pulsed Alexandrite Laser

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