MAXReach Laser Probe
FDA 510(k) K191846 · Vortex Surgical, Inc.
510(k) numberK191846
Submission
- Device name
- MAXReach Laser Probe
- Applicant
- Vortex Surgical, Inc.
Chesterfield, MO, US - Received
- July 10, 2019
- Decision date
- December 23, 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 |
| K110228 | Nidek Multicolor Laser PhotocoagulatorHQB · Special | Nidek Incorporated | 02/23/2011SE |
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More from Nk-Optik America
| 510(k) | Device | Decision |
|---|---|---|
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical…HQB · Traditional | 11/03/2022SE |
Questions and answers
When was MAXReach Laser Probe cleared by the FDA?
MAXReach Laser Probe (K191846) received a 510(k) decision of Substantially Equivalent on December 23, 2019, 166 days after the submission was received.
What is the product code of K191846?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.