510(k) K233516

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) by Reichert, Inc. — Product Code HKY

K233516 is an FDA 510(k) premarket notification submitted by Reichert, Inc. for the device "Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)". The FDA issued a decision of Substantially Equivalent on May 1, 2024. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Reichert, Inc. has at least 8 other 510(k) clearances on record.