FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Slit Lamp SL-D301
K Number: K161972
·
Decision Dec 9, 2016
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
13
Review Days
144
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Slit Lamp SL-D301
- K Number
- K161972
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Topcon Corporation
- Date Received
- July 18, 2016
- Decision Date
- December 9, 2016
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HJO), ordered by most recent decision date.
VISUREF 600
FDA 510(k)
FDA Class 2
·Ophthalmic
HP-OCT (HP-OCT)
FDA 510(k)
FDA Class 2
·Ophthalmic
Kowa SL-19
FDA 510(k)
FDA Class 2
·Ophthalmic
MiiS Horus Eye Anterior Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
Sunkingdom Slit Lamp
FDA 510(k)
FDA Class 2
·Ophthalmic
IOLMaster 700
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Topcon Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Nov 7, 2025 | Substantially Equivalent |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Jul 17, 2024 | Substantially Equivalent |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Apr 10, 2024 | Substantially Equivalent |
| K232828 | IMAGEnet6 Ophthalmic Data System | Mar 1, 2024 | Substantially Equivalent |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Oct 30, 2023 | Substantially Equivalent |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Aug 29, 2022 | Substantially Equivalent |
| K173119 | DRI OCT Triton | Jan 19, 2018 | Substantially Equivalent |
| K171370 | IMAGEnet 6 Ophthalmic Data System | Nov 1, 2017 | Substantially Equivalent |
| K170164 | 3D OCT-1 Maestro | Mar 3, 2017 | Substantially Equivalent |
| K161509 | 3D OCT-1 Maestro | Jul 28, 2016 | Substantially Equivalent |