Z-0607-2020Class III

TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of...

Name: Z-0607-2020 TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of...
Creator: Theralase Inc.
Published: 2019-09-26
License: https://open.fda.gov/license/

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

FDA source

Theralase Inc. began a recall of TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain on 2019-09-26. FDA classified it as Class III and gives the reason as "Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0607-2020
Classification: Class III
Status: Terminated
Initiated: 2019-09-26
Posted: 2019-12-05
Terminated: 2020-12-03
Recalling firm: Theralase Technologies Inc.
Product: TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Product code: NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Reason for recall: Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 26, 2019 the firm distributed Urgent Medical Device Recall Communication letters. Check the Serial Number on your TLC-2000 Power Pack (Model Number: TLC-2002) to see if your TLC-2000 is affected by the following issues: 1) The TLC-2000 Power Pack was shipped with a label identifying it as being CE compliant. What Should You Do?: No action required. The TLC-2000 is approved for sale in Canada under Medical Device License Number: 98357. The TLC-2000 is cleared for sale in the United States by the FDA under 510(k) number: K151816. *Product with Serial Number 3204 was sold in the European Union. Only the owner of Serial Number 3204 should return their TLC-2000. 2)The TLC-2000 was shipped without a Unique Device Identification (UDI) label. What Should You Do?: Please courier your TLC-2000 to Theralase, at your cost, for update. A UDI label will be added to your TLC-2000, at no charge and your TLC-2000 will be couriered back to you at Theralase's cost.
Quantity in commerce: 306 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.
Product codes and lots: Serial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0607-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0606-2020	Class III	Terminated	Voluntary: Firm initiated	2019-12-11	2020-02-18
Z-0607-2020	Class III	Terminated	Voluntary: Firm initiated	2019-12-11	2020-02-18

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)