Vitreq disposable laser probes, light fibers and Chandelier
FDA 510(k) K182646 · VitreQ BV
510(k) numberK182646
Submission
- Device name
- Vitreq disposable laser probes, light fibers and Chandelier
- Applicant
- VitreQ BV
Vierpolders, NL - Received
- September 24, 2018
- Decision date
- May 1, 2019
- 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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| K111493 | Nidek Multicolor Scan Laser Photocoagulator MC-500 VixiHQB · Traditional | Nidek Co., Ltd. | 07/27/2011SE |
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Questions and answers
When was Vitreq disposable laser probes, light fibers and Chandelier cleared by the FDA?
Vitreq disposable laser probes, light fibers and Chandelier (K182646) received a 510(k) decision of Substantially Equivalent on May 1, 2019, 219 days after the submission was received.
What is the product code of K182646?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.