Product code HOY
- Device name
- Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4750
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132042 | AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND | X6d, Ltd. | 2014-04-28 |
| K050856 | LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM | Ophthocare , Ltd. | 2005-05-31 |
| K971465 | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | National Healthcare Mfg. Corp. | 1997-06-04 |
| K944700 | ARCTIC PREMIER SERIES | Sungold Eyewear, Inc. | 1994-12-22 |
| K944857 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1994-12-15 |
| K945351 | SHIELD, EYE, OPHTHALMIC | Taiwan Eva Industrial Co., Inc. | 1994-12-13 |
| K945346 | MAKROLON 2405 GOGGLES (LIGHT AND DARK) | Universal Massage & Tanning, Inc. | 1994-11-22 |
| K942407 | AMCON SLIP IN MYDRIATIC SUNGLASSES | Amcon Laboratories, Inc. | 1994-06-06 |
| K941829 | SUN FILTERS/SHIELDS | Klinger Eye Shields, Inc. | 1994-05-17 |
| K930347 | SHAIDS PROTECTIVE GLASSES | Depuy, Inc. | 1994-04-29 |
| K940275 | UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD | P.J. Products, Inc. | 1994-03-24 |
| K940213 | UNIVERSAL CUSHIONED METAL EYE SHIELD | P.J. Products, Inc. | 1994-03-24 |
| K940095 | FOX EYE ALUMINUM SHIELD, OPHTHALMIC | P.J. Products, Inc. | 1994-03-01 |
| K930840 | POST-MYDS(TM) | Aukland Medical Plastics, Inc. | 1994-03-01 |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | American Threshold Industries, Inc. | 1993-11-12 |
| K931254 | GOGGLE SAFEGUARD | Sellstrom Mfg. Co. | 1993-11-12 |
| K925564 | ACTION MEDTEK/DENTEK EYEGLASSES | Action Eyewear Corp. | 1993-10-07 |
| K912576 | INSTRUMENT WIPE AND CORNEAL SHIELD | Katena Products, Inc. | 1992-01-31 |
| K914095 | PEEPERS TANNING GOGGLES | California Suncare, Inc. | 1991-10-30 |
| K913230 | UNIDIRECTIONAL OCCLUDER | Welch Allyn, Inc. | 1991-10-02 |
| K912367 | EYE BUBBLE | Aaron Medical Industries | 1991-10-02 |
| K900942 | OCULAR OCCLUDER | Microdynamics | 1990-05-25 |
| K900941 | OMNIPATCH | Eye Garter Company, Inc. | 1990-05-21 |
| K896681 | SOFT CORNEAL LIGHT SHIELD | Visitec Co. | 1990-01-11 |
| K896172 | STRAPPED EYE SHIELD | Eye Garter Company, Inc. | 1989-11-03 |
| K896171 | EYE PATCH | Eye Garter Company, Inc. | 1989-11-03 |
| K895364 | LID LOC | Spectrum Co. | 1989-10-31 |
| K894720 | UNIVERSAL EYESHIELD | Trident Medical Products, Inc. | 1989-09-14 |
| K894724 | SAFE-EDGE EYESHIELD | Trident Medical Products, Inc. | 1989-09-14 |
| K885163 | DIOPTICS EYESHIELDS | Dioptics | 1988-12-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08052276029638 | Eye Shield | AKTIVE SRL | 2024-01-15 |
| 10620974002069 | BetterShield™ | Southmedic Incorporated | 2020-10-02 |
| 10620974002878 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002861 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002854 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002847 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002830 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002823 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002816 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002809 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002793 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002786 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002779 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002762 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974002083 | BetterShield™ | Southmedic Incorporated | 2020-10-02 |
| 10620974002076 | BetterShield™ | Southmedic Incorporated | 2020-10-02 |
| 10620974001574 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| 10620974001116 | Clear Choice | Southmedic Incorporated | 2020-10-02 |
| M36812751 | Grafco | GF HEALTH PRODUCTS, INC. | 2020-10-01 |
| M36812731 | Grafco | GF HEALTH PRODUCTS, INC. | 2020-10-01 |
| 10612479210162 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-20 |
| 10612479210148 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-20 |
| 10612479210124 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-20 |
| 10381780509578 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-23 |
| 10304040051822 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10304040051815 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10381780404927 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780361619 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-28 |
| 08056093611106 | Doctor Smile / Doctor Diode Laser | LAMBDA SPA | 2016-12-15 |
| 08056093611090 | Doctor Smile / Doctor Diode Laser | LAMBDA SPA | 2016-12-01 |