Secret RF Small Handpiece

GUDID 08800016903331

CLASSYS Inc.

Intradermal radio-frequency ablation system
Primary Device ID08800016903331
NIH Device Record Keya45719b8-54b4-40b5-8607-a55e5fce862e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecret RF Small Handpiece
Version Model NumberMTR-C1
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS108800016903331 [Primary]
GS108800023200188 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-07
Device Publish Date2024-10-30

Devices Manufactured by CLASSYS Inc.

08800016905366 - VOLNEWMER S tip2025-06-24
08800016905373 - VOLNEWMER V tip2025-06-24
08800016905380 - VOLNEWMER F tip2025-06-24
08800016905397 - VOLNEWMER I tip2025-06-24
08800016905403 - VOLNEWMER S tip(D)2025-06-24
08800016905410 - VOLNEWMER V tip(D)2025-06-24
08800016905427 - VOLNEWMER F tip(D)2025-06-24
08800016905434 - VOLNEWMER I tip(D)2025-06-24

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.