Zyoptix XP Microkeratome
FDA 510(k) K040204 · Bausch & Lomb, Inc.
510(k) numberK040204
Submission
- Device name
- Zyoptix XP Microkeratome
- Applicant
- Bausch & Lomb, Inc.
Rochester, NY, US - Received
- January 29, 2004
- Decision date
- March 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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Questions and answers
When was Zyoptix XP Microkeratome cleared by the FDA?
Zyoptix XP Microkeratome (K040204) received a 510(k) decision of Substantially Equivalent on March 22, 2004, 53 days after the submission was received.
What is the product code of K040204?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.