FDA Product Code
FDA Product Code HOY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4750
510(k) Clearances — 55 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132042 | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND | X6d, Ltd. | 2014-04-28 | Traditional | PDF ↗ |
| K050856 | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM | Ophthocare , Ltd. | 2005-05-31 | Traditional | PDF ↗ |
| K971465 | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | National Healthcare Mfg. Corp. | 1997-06-04 | Traditional | PDF ↗ |
| K944700 | ARCTIC PREMIER SERIES | Sungold Eyewear, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K944857 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1994-12-15 | Traditional | PDF ↗ |
| K945351 | SHIELD, EYE, OPHTHALMIC | Taiwan Eva Industrial Co., Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K945346 | MAKROLON 2405 GOGGLES (LIGHT AND DARK) | Universal Massage & Tanning, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K942407 | AMCON SLIP IN MYDRIATIC SUNGLASSES | Amcon Laboratories, Inc. | 1994-06-06 | Traditional | PDF ↗ |
| K941829 | SUN FILTERS/SHIELDS | Klinger Eye Shields, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K930347 | SHAIDS PROTECTIVE GLASSES | Depuy, Inc. | 1994-04-29 | Traditional | PDF ↗ |
| K940213 | UNIVERSAL CUSHIONED METAL EYE SHIELD | P.J. Products, Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K940275 | UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD | P.J. Products, Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K940095 | FOX EYE ALUMINUM SHIELD, OPHTHALMIC | P.J. Products, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K930840 | POST-MYDS(TM) | Aukland Medical Plastics, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | American Threshold Industries, Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K931254 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1993-11-12 | Traditional | PDF ↗ |
| K925564 | ACTION MEDTEK/DENTEK EYEGLASSES | Action Eyewear Corp. | 1993-10-07 | Traditional | PDF ↗ |
| K912576 | INSTRUMENT WIPE AND CORNEAL SHIELD | Katena Products, Inc. | 1992-01-31 | Traditional | PDF ↗ |
| K914095 | PEEPERS TANNING GOGGLES | California Suncare, Inc. | 1991-10-30 | Traditional | PDF ↗ |
| K913230 | UNIDIRECTIONAL OCCLUDER | Welch Allyn, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K912367 | EYE BUBBLE | Aaron Medical Industries | 1991-10-02 | Traditional | PDF ↗ |
| K900942 | OCULAR OCCLUDER | Microdynamics | 1990-05-25 | Traditional | PDF ↗ |
| K900941 | OMNIPATCH | Eye Garter Company, Inc. | 1990-05-21 | Traditional | PDF ↗ |
| K896681 | SOFT CORNEAL LIGHT SHIELD | Visitec Co. | 1990-01-11 | Traditional | PDF ↗ |
| K896171 | EYE PATCH | Eye Garter Company, Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K896172 | STRAPPED EYE SHIELD | Eye Garter Company, Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K895364 | LID LOC | Spectrum Co. | 1989-10-31 | Traditional | PDF ↗ |
| K894724 | SAFE-EDGE EYESHIELD | Trident Medical Products, Inc. | 1989-09-14 | Traditional | PDF ↗ |
| K894720 | UNIVERSAL EYESHIELD | Trident Medical Products, Inc. | 1989-09-14 | Traditional | PDF ↗ |
| K885163 | DIOPTICS EYESHIELDS | Dioptics | 1988-12-30 | Traditional | PDF ↗ |
| K880489 | CLEAR EYE GARTER SHIELD | Eye Garter Company, Inc. | 1988-08-08 | Traditional | PDF ↗ |
| K881135 | COOL EYE(TM) EYE PROTECTOR | Cool Eyes, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K880666 | ULTRAVIOLET LIGHT PROTECTVE EYEWERE | Free Sun Intl. AB | 1988-06-28 | Traditional | PDF ↗ |
| K880490 | BLUE PLASTIC EYE SHIELD | Eye Garter Company, Inc. | 1988-05-03 | Traditional | PDF ↗ |
| K881232 | SURGIN EYE SHIELD | Surgeon Surgical Instrumentation, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K880675 | EASY SHIELD ADHESIVE BANDAGE | Eye Garter Company, Inc. | 1988-04-01 | Traditional | PDF ↗ |
| K875302 | MEDICAL EYE DISPOSABLE SHIELD | Bfd, Inc. | 1988-03-21 | Traditional | PDF ↗ |
| K875107 | HEALTH CARE EYE PROTECTION | Surgikos, Inc. | 1988-03-21 | Traditional | PDF ↗ |
| K873662 | WINK-EASE PERSONAL PROTECTIVE EYEWEAR | Eye Pro Medical Products, Inc. | 1987-10-02 | Traditional | PDF ↗ |
| K872659 | TAPELESS EYE SHIELD | Precision Therapeutics, Inc. | 1987-07-27 | Traditional | PDF ↗ |
| K872000 | EYE GARD | Treace Medical, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K863474 | KASEY EYE SHIELD | Kasey Enterprises, Inc. | 1986-09-24 | Traditional | PDF ↗ |
| K853035 | HESSBURG LIGHT GUARD | Visitec Co. | 1985-12-13 | Traditional | PDF ↗ |
| K852404 | LASERSAFE EYE SHIELDS | Lasersafe, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K844761 | SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD | Medical Instrument Development Laboratories, Inc. | 1984-12-24 | Traditional | PDF ↗ |
| K843961 | COLOR OPTIC CORNEAL EYE SHIELD | Colors IN Optics , Ltd. | 1984-11-28 | Traditional | PDF ↗ |
| K840834 | CORNEAL LIGHT SHIELD | Gabl, Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K840414 | COLOR OPTIC CORNEAL EYE SHIELD | Diversations, Inc. | 1984-08-15 | Traditional | PDF ↗ |
| K841599 | STORZ UNIVERSAL EYE SHIELD | Storz Instrument Co. | 1984-05-22 | Traditional | PDF ↗ |
| K840444 | NEONATE MASK FOR BABIES | Richards Medical Co., Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K833256 | CROUCH CORNEAL PROTECTOR | Star Instrument Co. | 1984-02-08 | Traditional | PDF ↗ |
| K821765 | PHOTOTHERAPY EYE PROTECTION FOR INFANTS | Russell Terry Co. | 1982-08-16 | Traditional | PDF ↗ |
| K811577 | CROUCH CORNEAL PROTECTOR | Denver Biomedicals, Inc. | 1981-08-07 | Traditional | PDF ↗ |
| K810098 | FOX EYE SHIELDS | American Hospital Supply Corp. | 1981-02-27 | Traditional | PDF ↗ |
| K802786 | POROPLAST-EYE DRESSING | Secol Co. | 1980-12-17 | Traditional | PDF ↗ |
Product code HOY · Class I · Ophthalmic. Data: openFDA.