Hansatome Microkeratome
FDA 510(k) K972808 · Chiron Vision Corp.
510(k) numberK972808
Submission
- Device name
- Hansatome Microkeratome
- Applicant
- Chiron Vision Corp.
Irvine, CA, US - Received
- July 28, 1997
- Decision date
- October 24, 1997
- 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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| K051486 | Norwood Abbey Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 07/06/2005SE |
| K043183 | Epi-KHNO · Traditional | Moria SA | 03/25/2005SE |
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| K970727 | Mport Foldable Lens Placement SystemMSS · Traditional | 12/17/1997SE |
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| K944995 | Iolab/Site Peristaltic ModuleHQC · Traditional | 10/05/1995SE |
| K951292 | Passport Foldable Lens Placement SystemKYB · Traditional | 06/02/1995SE |
| K944994 | Iolab/Site Disposable Diaphragm CassetteHQC · Traditional | 03/14/1995SE |
| K941550 | Automatic Corneal Shaper Surgical InstrumentHNO · Traditional | 11/22/1994SE |
| K935233 | Iolab Lacrimal Duct CatheterOKS · Traditional | 09/15/1994SE |
| K925606 | Optical Zone/Hexagonal/Astigmatism/Radial MarkersHMR · Traditional | 08/29/1994SE |
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Questions and answers
When was Hansatome Microkeratome cleared by the FDA?
Hansatome Microkeratome (K972808) received a 510(k) decision of Substantially Equivalent on October 24, 1997, 88 days after the submission was received.
What is the product code of K972808?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.