PinPointe FootLaser

GUDID 00108690800002

Short Pulsed Nd:YAG Laser

NUVOLASE INC.

Dermatological solid-state laser system
Primary Device ID00108690800002
NIH Device Record Key63060573-7f21-442b-9c62-b74fb9d1537b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePinPointe FootLaser
Version Model NumberPinPointe FootLaser
Company DUNS078274442
Company NameNUVOLASE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
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
GS100108690800002 [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 Date2016-08-31

On-Brand Devices [PinPointe FootLaser]

00108690800002Short Pulsed Nd:YAG Laser
00869080000207Short pulsed Nd:YAG laser

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