Visi-Drape Ophthalmic Drapes
FDA 510(k) K902857 · Visitec Co.
510(k) numberK902857
Submission
- Device name
- Visi-Drape Ophthalmic Drapes
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- June 29, 1990
- Decision date
- July 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMY – Keratome, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
Other 510(k)s with product code HMY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040297 | Oneuse- Plus MicrokeratomeHMY · Traditional | Moria SA | 03/31/2004SE |
| K023092 | BD K-4000 Microkeratome SystemHMY · Special | Becton, Dickinson & CO | 10/18/2002SE |
| K022637 | BD-3000 Microkeratome System, Model K-3000 MicrokeratomeHMY · Traditional | Becton, Dickinson & CO | 10/16/2002SE |
| K022560 | M2 Single Use MicrokertomeHMY · Traditional | Moria SA | 09/27/2002SE |
| K003594 | Carriazo Barraquer Single Use MicrokeratomeHMY · Traditional | Moria, Inc. | 03/09/2001SE |
| K002191 | Carriazo Barraquer II MicrokeratomeHMY · Traditional | Moria, Inc. | 10/12/2000SE |
| K992687 | Millenium Microkeratome, Model IMD-001HMY · Traditional | Industrial & Medical Design, Inc. | 09/24/1999SE |
| K984537 | Keratome System, Model K3000HMY · Traditional | Insight Technologies Instruments, LLC | 05/14/1999SE |
| K981741 | Carriazo Barraquer MicrokeratomeHMY · Traditional | Moria, Inc. | 07/24/1998SE |
| K974243 | Keratome SystemHMY · Traditional | Insight Technologies Instruments, LLC | 01/20/1998SE |
More from Insight Technologies Instruments, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
Questions and answers
When was Visi-Drape Ophthalmic Drapes cleared by the FDA?
Visi-Drape Ophthalmic Drapes (K902857) received a 510(k) decision of Substantially Equivalent on July 31, 1990, 32 days after the submission was received.
What is the product code of K902857?
The FDA product code is HMY – Keratome, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.