Wav50

GUDID 08800016905106

CLASSYS Inc.

Radio-frequency skin contouring system applicator tip
Primary Device ID08800016905106
NIH Device Record Keyd12bfa75-a9df-45c7-be25-b62e684c7b3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameWav50
Version Model NumberWAV50
Company DUNS689842183
Company NameCLASSYS Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS108800016905106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-10
Device Publish Date2025-07-02

Devices Manufactured by CLASSYS Inc.

08800016903140 - Max-252025-07-10
08800016903171 - Max-M252025-07-10
08800016903423 - Max-25C2025-07-10
08800016903447 - Max-64C2025-07-10
08800016903454 - Max-M25C2025-07-10
08800016904246 - MTR-AC-012025-07-10
08800016904253 - MTR-AC-042025-07-10
08800016904291 - MTR-AC-27G2025-07-10

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