Opd-Scan, Models ARK-10000 and ARK-9000
FDA 510(k) K003299 · Nidek Co., Ltd.
510(k) numberK003299
Submission
- Device name
- Opd-Scan, Models ARK-10000 and ARK-9000
- Applicant
- Nidek Co., Ltd.
Lake Forest, CA, US - Received
- October 20, 2000
- Decision date
- March 9, 2001
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLQ – Keratoscope, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1350
- Specialty
- Ophthalmic
Other 510(k)s with product code HLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973756 | Eye Sys VistaHLQ · Traditional | Eyesys Technologies, Inc. | 11/13/1997SE |
| K964290 | EyechekHLQ · Traditional | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 01/09/1997SE |
| K945382 | Technomed C-Scan Color Ellipsoid TopometerHLQ · Traditional | Expertech Assoc., Inc. | 01/31/1995SE |
| K944207 | Topographic Modeling System 2 TMS-2HLQ · Traditional | Computed Anatomy, Inc. | 12/07/1994SE |
| K944616 | Keratron Corneal TopographerHLQ · Traditional | Alliance Medical Marketinig | 11/22/1994SE |
| K940647 | Orbscan(Tm) KeratometerHLQ · Traditional | Orbtek, Inc. | 07/06/1994SE |
| K933556 | EH-270 Corneal TopographerHLQ · Traditional | Visioptic, Inc. | 11/02/1993SE |
| K923435 | Corneal Topography SystemHLQ · Traditional | Par Microsystems Corp. | 02/16/1993SE |
| K922253 | Keratoref L60HLQ · Traditional | Luneau Ophtalmologie SA | 06/19/1992SE |
| K912740 | ACT-1 (Anterior Corneal Topographer)HLQ · Traditional | Visionary Systems, Inc. | 12/30/1991SE |
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Questions and answers
When was Opd-Scan, Models ARK-10000 and ARK-9000 cleared by the FDA?
Opd-Scan, Models ARK-10000 and ARK-9000 (K003299) received a 510(k) decision of Unknown on March 9, 2001, 140 days after the submission was received.
What is the product code of K003299?
The FDA product code is HLQ – Keratoscope, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1350.