EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
FDA 510(k) K190875 · D.O.R.C. Dutch Ophthalmic Research Center (International)
510(k) numberK190875
Submission
- Device name
- EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
- Applicant
- D.O.R.C. Dutch Ophthalmic Research Center (International)
Zuidland, NL - Received
- April 4, 2019
- Decision date
- September 25, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
Other 510(k)s with product code HQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23…HQC · Special | Bausch and Lomb | 05/15/2026SE |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…HQC · Traditional | Bausch and Lomb, Incorporated | 03/25/2026SE |
| K250501 | System SophiHQC · Traditional | This AG | 11/14/2025SE |
| K243395 | MICOR 700 with Auto I/AHQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 08/08/2025SE |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621)…HQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 06/11/2025SE |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC · Traditional | Bausch and Lomb, Incorporated | 07/26/2024SE |
| K233398 | Faros Surgical SystemHQC · Traditional | Oertli Instrumente AG | 06/27/2024SE |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | Alcon Laboratories, Inc. | 06/21/2024SE |
| K232084 | Stellaris Elite vision enhancement systemHQC · Traditional | Bausch and Lomb | 02/26/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | Alcon Laboratories, Inc. | 01/10/2024SE |
More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213467 | EVA NEXUS Ophthalmic Surgical SystemHQC · Traditional | 06/14/2022SE |
Questions and answers
When was EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) cleared by the FDA?
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (K190875) received a 510(k) decision of Substantially Equivalent on September 25, 2019, 174 days after the submission was received.
What is the product code of K190875?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.