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ML 830®

MICROLIGHT CORPORATION OF AMERICA · Model ML-830-07-003 · UDI-DI 00859626006282

NHN

510(k) clearances

Adverse events

Recalls

Facilities

Description

SL Console

Recalls

Date	Firm	Reason
2019-09-26	Theralase Inc.	Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
2019-09-26	Theralase Inc.	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.
2019-09-26	Theralase Inc.	Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition
2019-09-26	Theralase Inc.	905 nm laser diodes may be below rated power output.
2019-09-26	Theralase Inc.	660 nm laser diodes may be below rated power output.
2019-09-26	Theralase Inc.	Device was shipped without a Unique Device Identification (UDI) label.
2019-09-26	Theralase Inc.	Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped vers

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.