Disposable Microkeratome Blades-Pe
FDA 510(k) K001176 · Oasis Medical, Inc.
510(k) numberK001176
Submission
- Device name
- Disposable Microkeratome Blades-Pe
- Applicant
- Oasis Medical, Inc.
Glendora, CA, US - Received
- April 11, 2000
- Decision date
- September 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HNO – Keratome, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
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| K082043 | Carriazo-Pendular MicrokeratomeHNO · Traditional | Schwind Eye-Tech-Solutions GmbH & Co. KG | 08/01/2008SE |
| K062465 | Zyoptix XP Epi Separator SystemHNO · Traditional | Bausch & Lomb, Inc. | 09/06/2006SE |
| K052891 | Horizon Epikeratome Disposable Microkeratome SystemHNO · Traditional | Hawken Industries | 03/23/2006SE |
| K051486 | Norwood Abbey Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 07/06/2005SE |
| K043183 | Epi-KHNO · Traditional | Moria SA | 03/25/2005SE |
| K043150 | Amadeus II EpikeratomeHNO · Special | Sis Ltd., Surgical Instrument Systems | 01/31/2005SE |
| K042083 | Modification to Visitome 20-10 MicrokeratomeHNO · Traditional | Biovision AG | 11/16/2004SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular PlugLZU · Traditional | 06/03/2022SE |
| K162361 | Soft Plug Extended Duration 180 Canalicular PlugLZU · Traditional | 04/17/2017SE |
| K032297 | Disposable N-Pe Mickrokeratome BladesHNO · Special | 08/26/2003SE |
| K030401 | Disposable M2-PE Microkeratome BladesHNO · Traditional | 06/19/2003SE |
| K022205 | Disposable N-Pe Microkeratome BladesHNO · Traditional | 10/03/2002SE |
| K013613 | Soft Plug Absorbable Plug-SaLZU · Traditional | 06/27/2002SE |
| K003820 | Disposable Cb-Pe Microkeratome BladesHNO · Traditional | 03/08/2001SE |
| K980437 | Silicone Punctal PlugLZU · Traditional | 04/30/1998SE |
| K950798 | Posterior Capsule ShieldHQC · Traditional | 05/22/1995SE |
| K950241 | Ophthalmic SpongesHOZ · Traditional | 02/27/1995SE |
Questions and answers
When was Disposable Microkeratome Blades-Pe cleared by the FDA?
Disposable Microkeratome Blades-Pe (K001176) received a 510(k) decision of Substantially Equivalent on September 21, 2000, 163 days after the submission was received.
What is the product code of K001176?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.