Yellow Laser Photocoagulator YLC-500
FDA 510(k) K170302 · Nidek Co., Ltd.
510(k) numberK170302
Submission
- Device name
- Yellow Laser Photocoagulator YLC-500
- Applicant
- Nidek Co., Ltd.
Gamagori, JP - Received
- January 31, 2017
- Decision date
- June 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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Questions and answers
When was Yellow Laser Photocoagulator YLC-500 cleared by the FDA?
Yellow Laser Photocoagulator YLC-500 (K170302) received a 510(k) decision of Substantially Equivalent on June 23, 2017, 143 days after the submission was received.
What is the product code of K170302?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.