PSI-TEC III Aspirator, 110V

FDA UDI

Class II (US FDA UDI)

by Mentor Texas LP

Identity

Trade Name: PSI-TEC III Aspirator, 110V FDA UDI
Generic Name: Liposuction system FDA UDI
Device Name: PSI-TEC III Aspirator, 110V FDA UDI
Model / Reference: PT-ASP-III-110 FDA UDI
Description: PSI-TEC III Aspirator, 110V FDA UDI

Identifiers

Catalog Number: PT-ASP-III-110 FDA UDI
Primary DI / UDI-DI: 00081317023364 FDA UDI
510(k) Number: K981215 FDA UDI
FDA Product Code: MUU FDA UDI
GMDN Term: Liposuction system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Liposuction system

PSI-TEC III Aspirator, 110V by Mentor Texas LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MicroAire® — MicroAire Surgical Instruments LLC · Class II
ORIGINS — Solta Medical, Inc. · Class II
Alma LipoFlow System 50Hz — ALMA LASERS LTD. · Class II
AirSculpt Handpiece — Millennium Medical Technologies, Inc. · Class II

Cleared under the same submission

K981215 also covers:

Accelerator II, Aspirator (110V) — Mentor Texas LP

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mentor Texas LP

Sources (1)

FDA UDI b99aa22f-9ff5-45d0-a78a-78cc4169627d 36 fields · synced May 30, 2026