Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi
FDA 510(k) K111493 · Nidek Co., Ltd.
510(k) numberK111493
Submission
- Device name
- Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi
- Applicant
- Nidek Co., Ltd.
Sunnyvale, CA, US - Received
- May 31, 2011
- Decision date
- July 27, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQB – Photocoagulator And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4690
- Specialty
- Ophthalmic
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Questions and answers
When was Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi cleared by the FDA?
Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (K111493) received a 510(k) decision of Substantially Equivalent on July 27, 2011, 57 days after the submission was received.
What is the product code of K111493?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.