FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
YELLOW LASER PHOTOCOAGULATOR YLC-500
K Number: K170302
·
Decision Jun 23, 2017
Classifications
1
FEI Numbers
61
Registration Numbers
62
Same Product Code
176
Applicant Total
13
Review Days
143
Basic Information
- Device Name
- YELLOW LASER PHOTOCOAGULATOR YLC-500
- K Number
- K170302
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NIDEK CO., LTD.
- Date Received
- January 31, 2017
- Decision Date
- June 23, 2017
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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