M-Pact Corneal Light Shield
FDA 510(k) K993883 · M-Pact Corp.
510(k) numberK993883
Submission
- Device name
- M-Pact Corneal Light Shield
- Applicant
- M-Pact Corp.
Eudora, KS, US - Received
- November 15, 1999
- Decision date
- December 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HOZ – Sponge, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4790
- Specialty
- Ophthalmic
Other 510(k)s with product code HOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132796 | Suntouch Eye SpearHOZ · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 10/30/2013SE |
| K130117 | Network Eye Spears, Points, Drains, Wicks and ShieldsHOZ · Traditional | Network Medical Products, Ltd. | 10/29/2013SE |
| K091240 | Alphamed Surgical Spear, Model 70-5000HOZ · Traditional | Alphamed, Inc. | 10/23/2009SE |
| K082460 | Cenefom Pva Surgical SpearHOZ · Traditional | Longtek Scientific Co., Ltd. | 12/15/2008SE |
| K012196 | Ultracell Absorbent StickHOZ · Traditional | Ultracell Medical Technologies, Inc. | 08/24/2001SE |
| K011191 | Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic SpongesHOZ · Traditional | Medtronic Xomed, Inc. | 06/26/2001SE |
| K003842 | Prescott's Surgical SpearHOZ · Traditional | Prescott'S, Inc. | 04/13/2001SE |
| K002279 | ML Eye Spear, Model ML 27 EsHOZ · Traditional | Med-Logics, Inc. | 08/18/2000SE |
| K990671 | Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument WipeHOZ · Traditional | Hurricane Medical | 05/10/1999SE |
| K990749 | Sof-Suction Fluid Evacuation SystemHOZ · Traditional | X-Tech Medical, LLC | 04/02/1999SE |
Questions and answers
When was M-Pact Corneal Light Shield cleared by the FDA?
M-Pact Corneal Light Shield (K993883) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 36 days after the submission was received.
What is the product code of K993883?
The FDA product code is HOZ – Sponge, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4790.