Polylase Polylase MX

GUDID 00860002307046

Dual Output Pulsed Alexandrite and Nd:YAG Laser

DDC TECHNOLOGIES, INC.

Dermatological solid-state laser system
Primary Device ID00860002307046
NIH Device Record Key4274030e-adc3-4bac-9ced-f9c4172dc4b9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolylase
Version Model NumberMX
Catalog NumberPolylase MX
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
GS100860002307046 [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

On-Brand Devices [Polylase]

90860002307018Pulsed Alexandrite Laser
00860002307046Dual Output Pulsed Alexandrite and Nd:YAG Laser
00860002307008Dual Output Pulsed Alexandrite and Nd:YAG Laser

Trademark Results [Polylase]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POLYLASE
POLYLASE
86787779 4987682 Live/Registered
DDC Technologies, Inc.
2015-10-14
POLYLASE
POLYLASE
78309466 2924439 Dead/Cancelled
DDC Technologies, Inc.
2003-10-04

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