HQE — Instrument, Vitreous Aspiration And Cutting, Ac-Powered Class II
FDA product code HQE covers "Instrument, Vitreous Aspiration And Cutting, Ac-Powered", a Class II medical device regulated under 21 CFR 886.4150. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQE
- Device Class
- Class II
- Regulation Number
- 886.4150
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212763 | visioncare devices | UniVit HE, UniVit UHS | August 10, 2022 |
| K170183 | a.r.c laser | Cetus system, Cetus probe | September 27, 2017 |
| K153168 | medical instrument development laboratories | Bi-Blade Vitrectomy Cutter | April 29, 2016 |
| K141065 | alcon research | CONSTELLATION VISION SYSTEM | August 22, 2014 |
| K121675 | synergetics | VERSAVIT | June 21, 2012 |
| K120170 | visioncare devices | PROCARE PLUS VITRECTOMY SYSTEM | May 30, 2012 |
| K102222 | medical instrument development laboratories | ULTIMATE VIT ENHAMCER (UVE) | April 8, 2011 |
| K033390 | microworld medical instruments | COLIBRI DISPOSABLE VITRECTOMY CUTTER | November 4, 2003 |
| K030948 | howard instruments | VMATE MODEL VMM1000 | June 17, 2003 |
| K023939 | visioncare devices | VELOCITY ADVANTAGE | April 17, 2003 |
| K020911 | medical instrument development laboratories | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | April 29, 2002 |
| K010082 | dutch ophthalmic usa | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | March 12, 2001 |
| K992943 | medical instrument development laboratories | VIT ENHANCER | December 10, 1999 |
| K990292 | ophthalmic consultants | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY P | November 19, 1999 |
| K983797 | dutch ophthalmic usa | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | March 3, 1999 |
| K980400 | peregrine surgical | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | April 30, 1998 |
| K980399 | peregrine surgical | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | April 30, 1998 |
| K980488 | storz instrument | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | March 23, 1998 |
| K970670 | altex vision | REUSABLE VITRECTOMY PROBE | May 6, 1997 |
| K970673 | altex vision | DISPOSABLE VITRECTOMY PROBE | May 5, 1997 |