Pro-Phaco Handpiece
FDA 510(k) K933503 · M. Imonti and Associates Inc.,
510(k) numberK933503
Submission
- Device name
- Pro-Phaco Handpiece
- Applicant
- M. Imonti and Associates Inc.,
San Juan Capistrano, CA, US - Received
- July 19, 1993
- Decision date
- January 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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| K233398 | Faros Surgical SystemHQC · Traditional | Oertli Instrumente AG | 06/27/2024SE |
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| 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 |
|---|---|---|
| K950800 | Pro-Pak for Oms DiplomateHQC · Traditional | 05/22/1995SE |
| K950799 | Pro-VitHQE · Traditional | 04/28/1995SE |
| K933627 | Phacofragmentor TipHQC · Traditional | 01/25/1994SE |
| K924551 | Endo Trachea Tube FixationCBH · Traditional | 12/08/1992SE |
| K905766 | Drainage Tube Restraint/Wound CoverGBX · Traditional | 03/06/1991SE |
Questions and answers
When was Pro-Phaco Handpiece cleared by the FDA?
Pro-Phaco Handpiece (K933503) received a 510(k) decision of Substantially Equivalent on January 6, 1994, 171 days after the submission was received.
What is the product code of K933503?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.