510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050342Substantially Equivalent

Theralase Tlc-1000 Therapeutic Medical Laser System

Theralase Technologies Inc., Markham, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050342 is the FDA 510(k) clearance record for THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM, a class II device, cleared for Theralase, Inc. on under FDA product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy). FDA's definition for product code NHN reads: "A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and...". FDA records list 2 510(k) clearances for Theralase Technologies Inc., from to . As of , FDA records show no recalls naming K050342.

Clearance record

Decision date
Received
(150 days to decision)
Product code
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Theralase, Inc. 600 Alden Rd., Markham, Ontario, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHN

Trailing 12 months
3 clearances under product code NHN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NHN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260