Applanation Tonometer HT-5000
FDA 510(k) K232143 · Huvitz Co., Ltd.
510(k) numberK232143
Submission
- Device name
- Applanation Tonometer HT-5000
- Applicant
- Huvitz Co., Ltd.
Anyang-Si, KR - Received
- July 19, 2023
- Decision date
- October 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKY – Tonometer, Manual
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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| K241447 | iCare ST500 (TA04)HKY · Traditional | Icare Finland OY | 09/27/2024SE |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)HKY · Traditional | Reichert, Inc. | 05/01/2024SE |
| K234037 | CATS-L Tonometer PrismHKY · Special | Cats Tonometer, LLC | 02/09/2024SE |
| K220852 | iCare IC200HKY · Traditional | Icare Finland OY | 10/06/2022SE |
| K211355 | iCare HOME2HKY · Traditional | Icare Finland OY | 01/25/2022SE |
| K203850 | CATS®-D Tonometer PrismHKY · Traditional | Cats Tonometer, LLC | 06/14/2021SE |
| K200966 | Icare HOME TonometerHKY · Special | Icare Finland OY | 05/07/2020SE |
| K190316 | Icare ic200HKY · Traditional | Icare Finland OY | 01/14/2020SE |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QHKY · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 12/19/2019SE |
| K182491 | Applanation tonometer AT-2HKY · Traditional | Takagi Seiko Co., Ltd. | 12/10/2018SE |
More from Takagi Seiko Co., Ltd.
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|---|---|---|
| K202097 | Fundus CameraHKI · Traditional | 02/02/2021SE |
| K191615 | Huvitz Imaging SystemNFJ · Special | 07/18/2019SE |
| K161829 | Huvitz Imaging SystemNFJ · Traditional | 04/06/2017SE |
| K093639 | Slit Lamp, Models HS-5000, HS-5500 and HS-7500HJO · Traditional | 12/03/2009SE |
| K073190 | Slit LampHJO · Traditional | 01/11/2008SE |
Questions and answers
When was Applanation Tonometer HT-5000 cleared by the FDA?
Applanation Tonometer HT-5000 (K232143) received a 510(k) decision of Substantially Equivalent on October 23, 2023, 96 days after the submission was received.
What is the product code of K232143?
The FDA product code is HKY – Tonometer, Manual, a Class II (moderate risk) device regulated under 21 CFR 886.1930.