PICO LEGEND

GUDID 08800042100292

AMI Inc.

General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID08800042100292
NIH Device Record Key52817a8f-ddb6-401e-89da-43b433caa0b0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePICO LEGEND
Version Model NumberPICO LEGEND
Company DUNS689004697
Company NameAMI 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800042100292 [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 Date2025-06-18
Device Publish Date2025-06-10

Devices Manufactured by AMI Inc.

08800042100292 - PICO LEGEND2025-06-18
08800042100292 - PICO LEGEND2025-06-18
08800042100001 - Q-MASTER2021-06-23
08800042100018 - BIOXEL2021-06-23

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