Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201
FDA 510(k) K010998 · Langham Ophthalmic Technologies
510(k) numberK010998
Submission
- Device name
- Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201
- Applicant
- Langham Ophthalmic Technologies
Timonium, MD, US - Received
- April 3, 2001
- Decision date
- June 27, 2001
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
Other 510(k)s with product code HKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253039 | Auto Kerato-Refracto Tonometer TRK-3 OmniaHKX · Traditional | Topcon Corporation | 11/07/2025SE |
| K223739 | VS Tabletop TonometerHKX · Traditional | Medimaging Integrated Solution, Inc. | 11/08/2023SE |
| K190382 | Intraocular Pressure Tonometer EASYTONHKX · Traditional | Company Elamed | 12/06/2019SE |
| K181260 | MiiS Horus Scope DPT 100HKX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 06/21/2019SE |
| K181143 | Keeler TonoCare TonometerHKX · Traditional | Keeler Instruments, Inc. | 02/08/2019SE |
| K180820 | Tono Vue Non-Contact TonometerHKX · Traditional | Crystalvue Medical Corporation | 12/14/2018SE |
| K162067 | VX130 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 04/24/2017SE |
| K143086 | VX120 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 06/01/2015SE |
| K113066 | Corvis STHKX · Traditional | Oculus Optikgerate GmbH | 11/08/2012SE |
| K111710 | Full Auto Tonometer Model TX-20HKX · Special | Canon Inc. -Medical Equipment Group | 09/20/2011SE |
Questions and answers
When was Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201 cleared by the FDA?
Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201 (K010998) received a 510(k) decision of Unknown on June 27, 2001, 85 days after the submission was received.
What is the product code of K010998?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.