FDA product code HNO: Keratome, Ac-Powered
HNO is the FDA product code for keratome, ac-powered. It is a Class I device, regulated under 21 CFR 886.4370 and reviewed by the Ophthalmic panel. FDA has cleared 83 510(k) submissions under HNO, from 40 different applicants. The average 510(k) review took 118 days (median 90). FDA has posted 10 recalls for HNO devices.
Classification
| Field | Value |
|---|---|
| Device name | Keratome, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.4370 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HNO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2018 | 1 | 168 |
Compare with all 510(k) review times · Search every HNO clearance
Top HNO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Logics, Inc. | 7 | 2004-01-13 |
| Millennium Biomedical, Inc. | 5 | 2004-10-13 |
| Oasis Medical, Inc. | 5 | 2003-08-26 |
| Bausch & Lomb, Inc. | 4 | 2006-09-06 |
| Micro Specialties, Inc. | 4 | 2004-05-25 |
35 more applicants have HNO clearances. See the full list in Caduvo.
Most recent HNO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173371 | Carl Zeiss Meditec, Inc. | VisuMax Femtosecond Laser | 2018-04-13 | 168 |
| K172994 | Moria SA | EPI K Console | 2017-10-26 | 29 |
| K072102 | Gebauer Medizintechnik GmbH | EPIVISION SL SYSTEM | 2009-01-16 | 535 |
| K082043 | Schwind Eye-Tech-Solutions GmbH & Co. KG | CARRIAZO-PENDULAR MICROKERATOME | 2008-08-01 | 14 |
| K062465 | Bausch & Lomb, Inc. | ZYOPTIX XP EPI SEPARATOR SYSTEM | 2006-09-06 | 13 |
Recalls for HNO devices
10 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-01-13.
Frequently asked questions
What is FDA product code HNO?
HNO is the FDA product code for keratome, ac-powered. It is a Class I device, regulated under 21 CFR 886.4370 and reviewed by the Ophthalmic panel.
What device class is HNO?
Class I, regulation 21 CFR 886.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code HNO?
Across 83 cleared submissions the average was 118 days from receipt to decision (median 90).
Which companies have the most HNO clearances?
Med-Logics, Inc. (7); Millennium Biomedical, Inc. (5); Oasis Medical, Inc. (5); Bausch & Lomb, Inc. (4); Micro Specialties, Inc. (4).
Have HNO devices been recalled?
Yes: 10 product recalls across 6 recall events; the most recent began 2015-01-13.
Next steps
- Run an FDA pathway report with predicate devices for product code HNO
- Run a recall and safety report across every HNO manufacturer
- Watch product code HNO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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