FDA product code HOS: Projector, Ophthalmic
HOS is the FDA product code for projector, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1680 and reviewed by the Ophthalmic panel. FDA has cleared 9 510(k) submissions under HOS, from 8 different applicants. The average 510(k) review took 101 days (median 79).
Classification
| Field | Value |
|---|---|
| Device name | Projector, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1680 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOS clearance
Top HOS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bausch & Lomb, Inc. | 2 | 1986-07-23 |
| Canon USA, Inc. | 1 | 1994-09-28 |
| Marco Ophthalmic, Inc. | 1 | 1993-07-06 |
| R.H. Burton Co. | 1 | 1993-04-05 |
| Luneau Ophtalmologie SA | 1 | 1992-06-11 |
3 more applicants have HOS clearances. See the full list in Caduvo.
Most recent HOS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K936200 | Canon USA, Inc. | WIRELESS CHART PROJECTOR,HCP-W 721 | 1994-09-28 | 273 |
| K930443 | Marco Ophthalmic, Inc. | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | 1993-07-06 | 161 |
| K924784 | R.H. Burton Co. | BURTON PROJECTOR HEAD - MODEL 6000-H | 1993-04-05 | 194 |
| K921214 | Luneau Ophtalmologie SA | OPHTHALMIC PROJECTOR | 1992-06-11 | 90 |
| K890992 | Woodlyn, Inc. | WOODLYN OPHTHALMIC PROJECTOR | 1989-05-17 | 79 |
Recalls for HOS devices
openFDA lists no recalls for product code HOS.
Frequently asked questions
What is FDA product code HOS?
HOS is the FDA product code for projector, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1680 and reviewed by the Ophthalmic panel.
What device class is HOS?
Class I, regulation 21 CFR 886.1680. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOS?
Across 9 cleared submissions the average was 101 days from receipt to decision (median 79).
Which companies have the most HOS clearances?
Bausch & Lomb, Inc. (2); Canon USA, Inc. (1); Marco Ophthalmic, Inc. (1); R.H. Burton Co. (1); Luneau Ophtalmologie SA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOS
- Run a recall and safety report across every HOS manufacturer
- Watch product code HOS 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times