Infinitech Aspirating Laser Probe
FDA 510(k) K946135 · Surgical Technologies, Inc.
510(k) numberK946135
Submission
- Device name
- Infinitech Aspirating Laser Probe
- Applicant
- Surgical Technologies, Inc.
Chesterfield, MO, US - Received
- December 16, 1994
- Decision date
- April 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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More from Visioncare Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941992 | CystoscopeFBO · Traditional | 11/30/1995SE |
| K942029 | ArthroscopeHRX · Traditional | 11/08/1995SE |
| K946136 | Infinitech Lighted Infusion CannulaMPA · Traditional | 10/02/1995SE |
| K952566 | OscilflatorMAV · Traditional | 08/31/1995SE |
| K951918 | Surgical Technologies, Inc. SyringeFMF · Traditional | 07/20/1995SE |
| K950683 | Arthrogram TrayJAA · Traditional | 05/06/1995SE |
| K946181 | Infinitech Soft Tip Flute NeedleHQE · Traditional | 03/14/1995SE |
| K942030 | Biopsy ScissorsOCZ · Traditional | 06/27/1994SE |
| K942482 | Pressure Monitoring ExtensionDQO · Traditional | 06/14/1994SE |
| K941161 | Flexible Grasping ForcepsEOQ · Traditional | 05/04/1994SE |
Questions and answers
When was Infinitech Aspirating Laser Probe cleared by the FDA?
Infinitech Aspirating Laser Probe (K946135) received a 510(k) decision of Substantially Equivalent on April 18, 1995, 123 days after the submission was received.
What is the product code of K946135?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.