FDA Medical Device Recalls (openFDA)
Theralase Inc.: TLC-2000 Therapeutic Medical Laser System
- Recall number
- Z-1354-2020
- Recalling firm
- Theralase Inc.
- Product
- TLC-2000 Therapeutic Medical Laser System
- Status
- Terminated
- Initiated
- 2019-09-26
- Posted
- 2020-02-13
- Terminated
- 2020-06-04
- Reason
- 905 nm laser diodes may be below rated power output.
- 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 905 nm laser diodes will be analyzed and recalibrated, as required, to meet rated power output.
- Quantity
- 92 units
- Distribution
- USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
- Lot, serial or model codes
- Serial Numbers: 3245 to 3336 inclusive
- 510(k) numbers
- ["K151816"]
- PMA numbers
- not on file
- Product code
- NHN
- Firm FEI
- 3003614490
- Firm city
- East York
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28