Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4750](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4750) → HOY — Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) # HOY · Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) _Ophthalmic · 21 CFR 886.4750 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY ## Overview - **Product Code:** HOY - **Device Name:** Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) - **Regulation:** [21 CFR 886.4750](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4750) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) - **GMP exempt:** yes ## Identification An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place. ## Classification Rationale Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. ## Recent Cleared Devices (20 of 55) Showing 20 most recent of 55 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K132042](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K132042.md) | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND | X6d, Ltd. | Apr 28, 2014 | SESE | | [K050856](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K050856.md) | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM | Ophthocare , Ltd. | May 31, 2005 | SESE | | [K971465](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K971465.md) | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | National Healthcare Mfg. Corp. | Jun 4, 1997 | SESE | | [K944700](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K944700.md) | ARCTIC PREMIER SERIES | Sungold Eyewear, Inc. | Dec 22, 1994 | SESE | | [K944857](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K944857.md) | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | Dec 15, 1994 | SESE | | [K945351](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K945351.md) | SHIELD, EYE, OPHTHALMIC | Taiwan Eva Industrial Co., Inc. | Dec 13, 1994 | SESE | | [K945346](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K945346.md) | MAKROLON 2405 GOGGLES (LIGHT AND DARK) | Universal Massage & Tanning, Inc. | Nov 22, 1994 | SESE | | [K942407](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K942407.md) | AMCON SLIP IN MYDRIATIC SUNGLASSES | Amcon Laboratories, Inc. | Jun 6, 1994 | SESE | | [K941829](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K941829.md) | SUN FILTERS/SHIELDS | Klinger Eye Shields, Inc. | May 17, 1994 | SESE | | [K930347](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K930347.md) | SHAIDS PROTECTIVE GLASSES | Depuy, Inc. | Apr 29, 1994 | SESE | | [K940275](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K940275.md) | UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD | P.J. Products, Inc. | Mar 24, 1994 | SESE | | [K940213](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K940213.md) | UNIVERSAL CUSHIONED METAL EYE SHIELD | P.J. Products, Inc. | Mar 24, 1994 | SESE | | [K940095](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K940095.md) | FOX EYE ALUMINUM SHIELD, OPHTHALMIC | P.J. Products, Inc. | Mar 1, 1994 | SESE | | [K930840](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K930840.md) | POST-MYDS(TM) | Aukland Medical Plastics, Inc. | Mar 1, 1994 | SESE | | [K934085](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K934085.md) | MODIFICATION OF SURGICAL EYESHIELD MASK | American Threshold Industries, Inc. | Nov 12, 1993 | SESE | | [K931254](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K931254.md) | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | Nov 12, 1993 | SESE | | [K925564](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K925564.md) | ACTION MEDTEK/DENTEK EYEGLASSES | Action Eyewear Corp. | Oct 7, 1993 | SESE | | [K912576](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K912576.md) | INSTRUMENT WIPE AND CORNEAL SHIELD | Katena Products, Inc. | Jan 31, 1992 | SESE | | [K914095](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K914095.md) | PEEPERS TANNING GOGGLES | California Suncare, Inc. | Oct 30, 1991 | SESE | | [K913230](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K913230.md) | UNIDIRECTIONAL OCCLUDER | Welch Allyn, Inc. | Oct 2, 1991 | SESE | ## Top Applicants - Eye Garter Company, Inc. — 6 clearances - P.J. Products, Inc. — 3 clearances - Visitec Co. — 2 clearances - Trident Medical Products, Inc. — 2 clearances - Sellstrom Mfg. Co. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com