Z-1353-2020Class III

TLC-2000 Therapeutic Medical Laser System

Name: Z-1353-2020 TLC-2000 Therapeutic Medical Laser System
Creator: Theralase Inc.
Published: 2019-09-26
License: https://open.fda.gov/license/

Theralase Technologies Inc. / initiated 2019-09-26 / Terminated / root cause: design

FDA source

Theralase Inc. began a recall of TLC-2000 Therapeutic Medical Laser System on 2019-09-26. FDA classified it as Class III and gives the reason as "660 nm laser diodes may be below rated power output". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1353-2020
Classification: Class III
Status: Terminated
Initiated: 2019-09-26
Posted: 2020-02-24
Terminated: 2020-12-03
Recalling firm: Theralase Technologies Inc.
Product: TLC-2000 Therapeutic Medical Laser System
Product code: NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Reason for recall: 660 nm laser diodes may be below rated power output.
Root cause tag: design
FDA root cause: Device Design
Action: Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase for analysis. Their 660 nm laser diodes will be analyzed and recalibrated / replaced, as required, to meet rated power output.
Quantity in commerce: 92 units
Distribution: USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Product codes and lots: Serial Numbers: 3245 to 3336 (inclusive)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1353-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1353-2020	Class III	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-24

Product code NHN

K151816Class IITLC-2000 Therapeutic Medical Laser SystemTheralase, Inc. / cleared 2015-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)