truSculpt 16

GUDID 00816722022400

Radio-frequency skin contouring system

Primary Device ID	00816722022400
NIH Device Record Key	9fb54233-be3c-44e8-a1c7-5511d7d8a224
Commercial Distribution Status	In Commercial Distribution
Brand Name	truSculpt 16
Version Model Number	truSculpt 16
Company DUNS	041071643
Company Name	CUTERA, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00816722022400 [Primary]

PBX	Massager, Vacuum, Radio Frequency Induced Heat

Steralize Prior To Use	false
Device Is Sterile	false

00816722022806 - Acutip	2023-05-23 Acutip IPL Handpiece for xeo+/xeo+ SA
00816722021809 - xeo+	2022-12-08 xeo+ Laser System
00816722021816 - xeo+ SA	2022-12-08 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 - Titan	2022-12-08 Titan IPL Handpiece for xeo+/xeo+ SA
00816722022844 - Pearl Fractional	2022-12-08 Pearl Fractional Laser Handpiece for xeo+/xeo+ SA
00816722022479 - truSculpt 2 RF handpiece	2022-11-22 truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device