Acutip

GUDID 00816722022806

Acutip IPL Handpiece for xeo+/xeo+ SA

CUTERA, INC.

Light-energy skin surface treatment system applicator
Primary Device ID00816722022806
NIH Device Record Keyf34a5115-1dc7-4a2c-9051-624b816b7b0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcutip
Version Model NumberAcutip
Company DUNS041071643
Company NameCUTERA, 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
GS100816722022806 [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 Date2023-05-23
Device Publish Date2023-05-15

Devices Manufactured by CUTERA, INC.

00816722022806 - Acutip2023-05-23Acutip IPL Handpiece for xeo+/xeo+ SA
00816722022806 - Acutip2023-05-23 Acutip IPL Handpiece for xeo+/xeo+ SA
00816722021809 - xeo+2022-12-08 xeo+ Laser System
00816722021816 - xeo+ SA2022-12-08 xeo+ SA IPL System
00816722022813 - Limelight 2022-12-08 Limelight IPL Handpiece for xeo+/xeo+ SA
00816722022820 - Prowave 2022-12-08 Prowave IPL Handpiece for xeo+/xeo+ SA
00816722022837 - Titan2022-12-08 Titan IPL Handpiece for xeo+/xeo+ SA
00816722022844 - Pearl Fractional2022-12-08 Pearl Fractional Laser Handpiece for xeo+/xeo+ SA
00816722022479 - truSculpt 2 RF handpiece2022-11-22 truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.