FDA product code HOY: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
HOY is the FDA product code for shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear). It is a Class I device, regulated under 21 CFR 886.4750 and reviewed by the Ophthalmic panel. FDA has cleared 55 510(k) submissions under HOY, from 45 different applicants. The average 510(k) review took 98 days (median 63). FDA has posted 1 recall for HOY devices.
Classification
| Field | Value |
|---|---|
| Device name | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| Device class | Class I |
| Regulation | 21 CFR 886.4750 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HOY clearance
Top HOY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eye Garter Company, Inc. | 6 | 1990-05-21 |
| P.J. Products, Inc. | 3 | 1994-03-24 |
| Sellstrom Mfg. Co. | 2 | 1994-12-15 |
| Visitec Co. | 2 | 1990-01-11 |
| Trident Medical Products, Inc. | 2 | 1989-09-14 |
40 more applicants have HOY clearances. See the full list in Caduvo.
Most recent HOY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132042 | X6d, Ltd. | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND | 2014-04-28 | 300 |
| K050856 | Ophthocare , Ltd. | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM | 2005-05-31 | 56 |
| K971465 | National Healthcare Mfg. Corp. | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | 1997-06-04 | 43 |
| K944700 | Sungold Eyewear, Inc. | ARCTIC PREMIER SERIES | 1994-12-22 | 90 |
| K944857 | Sellstrom Mfg. Co. | GOGGLE SAFEGUARD | 1994-12-15 | 76 |
Recalls for HOY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-06-05.
Frequently asked questions
What is FDA product code HOY?
HOY is the FDA product code for shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear). It is a Class I device, regulated under 21 CFR 886.4750 and reviewed by the Ophthalmic panel.
What device class is HOY?
Class I, regulation 21 CFR 886.4750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOY?
Across 55 cleared submissions the average was 98 days from receipt to decision (median 63).
Which companies have the most HOY clearances?
Eye Garter Company, Inc. (6); P.J. Products, Inc. (3); Sellstrom Mfg. Co. (2); Visitec Co. (2); Trident Medical Products, Inc. (2).
Have HOY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code HOY
- Run a recall and safety report across every HOY manufacturer
- Watch product code HOY 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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