HKX — Tonometer, Ac-Powered Class II
FDA product code HKX covers "Tonometer, Ac-Powered", a Class II medical device regulated under 21 CFR 886.1930. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HKX
- Device Class
- Class II
- Regulation Number
- 886.1930
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253039 | topcon corporation | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | November 7, 2025 |
| K223739 | medimaging integrated solution | VS Tabletop Tonometer | November 8, 2023 |
| K190382 | company elamed | Intraocular Pressure Tonometer EASYTON | December 6, 2019 |
| K181260 | medimaging integrated solution, inc (miis) | MiiS Horus Scope DPT 100 | June 21, 2019 |
| K181143 | keeler instruments | Keeler TonoCare Tonometer | February 8, 2019 |
| K180820 | crystalvue medical corporation | Tono Vue Non-Contact Tonometer | December 14, 2018 |
| K162067 | luneau | VX130 Ophthalmic Diagnostic Device | April 24, 2017 |
| K143086 | luneau | VX120 Ophthalmic Diagnostic Device | June 1, 2015 |
| K113066 | oculus optikgerate | CORVIS ST | November 8, 2012 |
| K111710 | canon inc. -medical equipment group | FULL AUTO TONOMETER MODEL TX-20 | September 20, 2011 |
| K093298 | keeler instruments | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | December 10, 2010 |
| K083377 | accutome ultrasound | ACCUPEN | July 27, 2009 |
| K073087 | tomey corporation | NON-CONTACT TONOMETER, MODEL FT-1000 | November 18, 2008 |
| K081756 | reichert | OCULAR RESPONSE ANALYZER | August 7, 2008 |
| K053444 | kowa co. | KOWA KT-800 | June 9, 2006 |
| K060780 | ryazan state instruments | TONOMETER DIATON | April 6, 2006 |
| K042099 | retinapharma technologies | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) | December 10, 2004 |
| K032799 | reichert | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | January 20, 2004 |
| K031733 | nidek | NON-CONTACT TONOMETER, MODEL NT-4000 | December 4, 2003 |
| K023676 | optilasa, s.l | APPLANATION TONOMETER | April 24, 2003 |