Fraxis Main Unit

GUDID 08800016903966

CLASSYS Inc.

Dermatological carbon dioxide laser system
Primary Device ID08800016903966
NIH Device Record Keybb7ecfed-d56d-44f9-a8fa-908c3e04e283
Commercial Distribution StatusIn Commercial Distribution
Brand NameFraxis Main Unit
Version Model NumberFRX-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
GS108800016903966 [Primary]
GS108800023200881 [Previous]

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 Date2024-11-07
Device Publish Date2024-10-30

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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