FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K Number: K003299
·
Decision Mar 9, 2001
Classifications
1
FEI Numbers
17
Registration Numbers
18
Same Product Code
28
Applicant Total
20
Review Days
140
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Basic Information
- Device Name
- OPD-SCAN, MODELS ARK-10000 AND ARK-9000
- K Number
- K003299
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Nidek Co., Ltd.
- Date Received
- October 20, 2000
- Decision Date
- March 9, 2001
- Product Code
- HLQ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HLQ | Keratoscope, Ac-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Nidek Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| K203130 | Ophthalmic Yag Laser System YC-200 | Dec 7, 2020 | Substantially Equivalent |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nov 15, 2019 | Substantially Equivalent |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Apr 1, 2019 | Substantially Equivalent |
| K181345 | Image Filing Software NAVIS-EX | Jul 19, 2018 | Substantially Equivalent |
| K173980 | Specular Microscope CEM-530 | Mar 14, 2018 | Substantially Equivalent |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | Jun 23, 2017 | Substantially Equivalent |
| K163564 | SLIT LAMP SL-2000 | May 19, 2017 | Substantially Equivalent |
| K152729 | MICROPERIMETER MP-3 | Jun 6, 2016 | Substantially Equivalent |
| K152603 | Green Laser Photocoagulator GYC-500 | May 2, 2016 | Substantially Equivalent |