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 | Aug 10, 2022 |
| K170183 | A.R.C Laser | Cetus system, Cetus probe | Sep 27, 2017 |
| K153168 | Medical Instrument Development Laboratories | Bi-Blade Vitrectomy Cutter | Apr 29, 2016 |
| K141065 | Alcon Research | CONSTELLATION VISION SYSTEM | Aug 22, 2014 |
| K121675 | Synergetics | VERSAVIT | Jun 21, 2012 |
| K120170 | Visioncare Devices | PROCARE PLUS VITRECTOMY SYSTEM | May 30, 2012 |
| K102222 | Medical Instrument Development Laboratories | ULTIMATE VIT ENHAMCER (UVE) | Apr 8, 2011 |
| K033390 | Microworld Medical Instruments | COLIBRI DISPOSABLE VITRECTOMY CUTTER | Nov 4, 2003 |
| K030948 | Howard Instruments | VMATE MODEL VMM1000 | Jun 17, 2003 |
| K023939 | Visioncare Devices | VELOCITY ADVANTAGE | Apr 17, 2003 |
| K020911 | Medical Instrument Development Laboratories | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Apr 29, 2002 |
| K010082 | Dutch Ophthalmic Usa | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Mar 12, 2001 |
| K992943 | Medical Instrument Development Laboratories | VIT ENHANCER | Dec 10, 1999 |
| K990292 | Ophthalmic Consultants | I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY P | Nov 19, 1999 |
| K983797 | Dutch Ophthalmic Usa | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Mar 3, 1999 |
| K980400 | Peregrine Surgical | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | Apr 30, 1998 |
| K980399 | Peregrine Surgical | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | Apr 30, 1998 |
| K980488 | Storz Instrument | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Mar 23, 1998 |
| K970670 | Altex Vision | REUSABLE VITRECTOMY PROBE | May 6, 1997 |
| K970673 | Altex Vision | DISPOSABLE VITRECTOMY PROBE | May 5, 1997 |