HOY · Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Ophthalmic · 21 CFR 886.4750 · Class 1
Overview
| Product Code | HOY |
|---|---|
| Device Name | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| Regulation | 21 CFR 886.4750 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| 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.
Cleared Devices (55)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132042 | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND | X6d, Ltd. | Apr 28, 2014 | SESE |
| K050856 | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM | Ophthocare , Ltd. | May 31, 2005 | SESE |
| K971465 | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | National Healthcare Mfg. Corp. | Jun 4, 1997 | SESE |
| K944700 | ARCTIC PREMIER SERIES | Sungold Eyewear, Inc. | Dec 22, 1994 | SESE |
| K944857 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | Dec 15, 1994 | SESE |
| K945351 | SHIELD, EYE, OPHTHALMIC | Taiwan Eva Industrial Co., Inc. | Dec 13, 1994 | SESE |
| K945346 | MAKROLON 2405 GOGGLES (LIGHT AND DARK) | Universal Massage & Tanning, Inc. | Nov 22, 1994 | SESE |
| K942407 | AMCON SLIP IN MYDRIATIC SUNGLASSES | Amcon Laboratories, Inc. | Jun 6, 1994 | SESE |
| K941829 | SUN FILTERS/SHIELDS | Klinger Eye Shields, Inc. | May 17, 1994 | SESE |
| K930347 | SHAIDS PROTECTIVE GLASSES | Depuy, Inc. | Apr 29, 1994 | SESE |
| K940275 | UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD | P.J. Products, Inc. | Mar 24, 1994 | SESE |
| K940213 | UNIVERSAL CUSHIONED METAL EYE SHIELD | P.J. Products, Inc. | Mar 24, 1994 | SESE |
| K940095 | FOX EYE ALUMINUM SHIELD, OPHTHALMIC | P.J. Products, Inc. | Mar 1, 1994 | SESE |
| K930840 | POST-MYDS(TM) | Aukland Medical Plastics, Inc. | Mar 1, 1994 | SESE |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | American Threshold Industries, Inc. | Nov 12, 1993 | SESE |
| K931254 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | Nov 12, 1993 | SESE |
| K925564 | ACTION MEDTEK/DENTEK EYEGLASSES | Action Eyewear Corp. | Oct 7, 1993 | SESE |
| K912576 | INSTRUMENT WIPE AND CORNEAL SHIELD | Katena Products, Inc. | Jan 31, 1992 | SESE |
| K914095 | PEEPERS TANNING GOGGLES | California Suncare, Inc. | Oct 30, 1991 | SESE |
| K913230 | UNIDIRECTIONAL OCCLUDER | Welch Allyn, Inc. | Oct 2, 1991 | SESE |
| K912367 | EYE BUBBLE | Aaron Medical Industries | Oct 2, 1991 | SESE |
| K900942 | OCULAR OCCLUDER | Microdynamics | May 25, 1990 | SESE |
| K900941 | OMNIPATCH | Eye Garter Company, Inc. | May 21, 1990 | SESE |
| K896681 | SOFT CORNEAL LIGHT SHIELD | Visitec Co. | Jan 11, 1990 | SESE |
| K896172 | STRAPPED EYE SHIELD | Eye Garter Company, Inc. | Nov 3, 1989 | SESE |
| K896171 | EYE PATCH | Eye Garter Company, Inc. | Nov 3, 1989 | SESE |
| K895364 | LID LOC | Spectrum Co. | Oct 31, 1989 | SESE |
| K894724 | SAFE-EDGE EYESHIELD | Trident Medical Products, Inc. | Sep 14, 1989 | SESE |
| K894720 | UNIVERSAL EYESHIELD | Trident Medical Products, Inc. | Sep 14, 1989 | SESE |
| K885163 | DIOPTICS EYESHIELDS | Dioptics | Dec 30, 1988 | SESE |
| K880489 | CLEAR EYE GARTER SHIELD | Eye Garter Company, Inc. | Aug 8, 1988 | SESE |
| K881135 | COOL EYE(TM) EYE PROTECTOR | Cool Eyes, Inc. | Jul 8, 1988 | SESE |
| K880666 | ULTRAVIOLET LIGHT PROTECTVE EYEWERE | Free Sun Intl. AB | Jun 28, 1988 | SESE |
| K880490 | BLUE PLASTIC EYE SHIELD | Eye Garter Company, Inc. | May 3, 1988 | SESE |
| K881232 | SURGIN EYE SHIELD | Surgeon Surgical Instrumentation, Inc. | Apr 13, 1988 | SESE |
| K880675 | EASY SHIELD ADHESIVE BANDAGE | Eye Garter Company, Inc. | Apr 1, 1988 | SESE |
| K875302 | MEDICAL EYE DISPOSABLE SHIELD | Bfd, Inc. | Mar 21, 1988 | SESE |
| K875107 | HEALTH CARE EYE PROTECTION | Surgikos, Inc. | Mar 21, 1988 | SESE |
| K873662 | WINK-EASE PERSONAL PROTECTIVE EYEWEAR | Eye Pro Medical Products, Inc. | Oct 2, 1987 | SESE |
| K872659 | TAPELESS EYE SHIELD | Precision Therapeutics, Inc. | Jul 27, 1987 | SESE |
| K872000 | EYE GARD | Treace Medical, Inc. | Jul 21, 1987 | SESE |
| K863474 | KASEY EYE SHIELD | Kasey Enterprises, Inc. | Sep 24, 1986 | SESE |
| K853035 | HESSBURG LIGHT GUARD | Visitec Co. | Dec 13, 1985 | SESE |
| K852404 | LASERSAFE EYE SHIELDS | Lasersafe, Inc. | Oct 4, 1985 | SESE |
| K844761 | SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD | Medical Instrument Development Laboratories, Inc. | Dec 24, 1984 | SESE |
| K843961 | COLOR OPTIC CORNEAL EYE SHIELD | Colors IN Optics , Ltd. | Nov 28, 1984 | SESE |
| K840834 | CORNEAL LIGHT SHIELD | Gabl, Inc. | Oct 5, 1984 | SESE |
| K840414 | COLOR OPTIC CORNEAL EYE SHIELD | Diversations, Inc. | Aug 15, 1984 | SESE |
| K841599 | STORZ UNIVERSAL EYE SHIELD | Storz Instrument Co. | May 22, 1984 | SESE |
| K840444 | NEONATE MASK FOR BABIES | Richards Medical Co., Inc. | Mar 16, 1984 | SESE |
| K833256 | CROUCH CORNEAL PROTECTOR | Star Instrument Co. | Feb 8, 1984 | SESE |
| K821765 | PHOTOTHERAPY EYE PROTECTION FOR INFANTS | Russell Terry Co. | Aug 16, 1982 | SESE |
| K811577 | CROUCH CORNEAL PROTECTOR | Denver Biomedicals, Inc. | Aug 7, 1981 | SESE |
| K810098 | FOX EYE SHIELDS | American Hospital Supply Corp. | Feb 27, 1981 | SESE |
| K802786 | POROPLAST-EYE DRESSING | Secol Co. | Dec 17, 1980 | 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
