StoneLight 15 NS1800

GUDID 00859932006013

Ho:YAG Laser System

NEW STAR LASERS, INC.

General/multiple surgical solid-state laser system
Primary Device ID00859932006013
NIH Device Record Key6f2d0206-8d10-4dab-b463-7bf3413c6524
Commercial Distribution StatusIn Commercial Distribution
Brand NameStoneLight 15
Version Model Number7300-0028
Catalog NumberNS1800
Company DUNS877266163
Company NameNEW STAR LASERS, 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 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
GS100859932006013 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

Devices Manufactured by NEW STAR LASERS, INC.

00859932006013 - StoneLight 152018-07-06Ho:YAG Laser System
00859932006013 - StoneLight 152018-07-06 Ho:YAG Laser System
00859932006211 - New Star Lasers2018-07-06 Fiber Optic Catheter
00859932006228 - New Star Lasers2018-07-06 Fiber Optic Catheter
00859932006235 - New Star Lasers2018-07-06 Fiber Optic Catheter
00859932006242 - New Star Lasers2018-07-06 Fiber Optic Catheter
00859932006006 - StoneLight 302018-03-29 Ho:YAG Laser System
00859932006020 - CoolTouch CTEV2018-03-29 Nd:YAG Laser System
00859932006037 - CoolTouch ReNew2018-03-29 Nd:YAG Laser System

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