LaserMe 100-1600

GUDID 00850017374188

The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

NEAUVIA NORTH AMERICA, INC.

Dermatological solid-state laser system
Primary Device ID00850017374188
NIH Device Record Keyf23172e6-58c4-4c5c-a684-e81b7aa8bf85
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaserMe
Version Model Number100-1600
Catalog Number100-1600
Company DUNS117030786
Company NameNEAUVIA NORTH AMERICA, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017374188 [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 Date2023-08-23
Device Publish Date2023-08-15

Devices Manufactured by NEAUVIA NORTH AMERICA, INC.

00850017374188 - LaserMe2023-08-23The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
00850017374188 - LaserMe2023-08-23 The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedure
00850017374201 - EpilMe System2022-10-11 Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of gen
00850017374218 - EpilMe Applicator2022-10-11 Handpiece applicator for EpilMe System
00850017374126 - Sectum System2021-10-05
00850017374133 - Sectum Precise (Face) Applicator2021-10-05
00850017374140 - Sectum Body Applicator2021-10-05
00850017374157 - Sectum Foot Switch2021-10-05 Foot switch for the Sectum System
00850017374164 - Sectum Cable Body Applicator2021-10-05

Trademark Results [LaserMe]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LASERME
LASERME
97305363 not registered Live/Pending
Neauvia North America, Inc.
2022-03-10
LASERME
LASERME
79359182 not registered Live/Pending
MATEX LAB SWITZERLAND SA
2022-06-09

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