510(k) K790251
- Device
- FUL-VUE ASPHERIC CATARACT LENS
- Applicant
- AMERICAN OPTICAL CORP.
- 510(k) number
- K790251
- Product code
- HQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-02-26
- Date received
- 1979-02-06
- Regulation
- 886.5844
- Classification name
- Lens, Spectacle, Non-custom (prescription)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3030643434
- 3006755718
- 3022260441
- 3005785090
- 3009490031
- 3030514700
- 3038208112
- 2081003
- 3010107381
- 3007088216
- 3005211969
- 3015169733
- 3011505252
- 3012395063
- 3010865508
- 3031755043
- 3008101408
- 3007865200
- 2031962
- 3030492158
- 8030290
- 3011532790
- 3014589856
- 3013532963
- 3042927805
- 3010408842
- 3003433048
- 3034695202
- 3030510804
- 3025350033
- 3011518249
- 1218954
- 3013510936
- 3029975226
- 3011644027
- 3014607554
- 3004167027
- 3010399203
- 3012879963
- 3038597556
- 3010990456
- 3006608227
- 3003082366
- 3003488848
- 3035140839
- 9617875
- 3040388420
- 3005246919
- 9680850
- 3014329429
- 3003668653
- 3009770970
- 3033891197
- 3016170487
- 3010526253
- 3042284353
- 8043097
- 3042896809
- 3010617503
- 3014888885
- 3016244741
- 3010189794
- 3027783184
- 3009233789
- 3020602066
- 3014240484
- 3003902746
- 3003805077
- 3017767230
- 1937310
- 3005094451
- 3006540519
- 3016595584
- 3016593276
- 9615561
- 3031599350
- 1215866
- 3008044481
- 3013170369
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935919 | SUNGLASSES | Ja-Ru, Inc. | 1994-02-16 |
| K920795 | 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX | Optical Radiation Corp. | 1992-07-13 |
| K900091 | MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR | Onufryk Low Vision Ent. | 1990-04-04 |
| K884360 | SEIKO P-6 PROGRESSIVE SPECTACLE LENSES | Seiko Corp. | 1988-11-15 |
| K882814 | NEOLENS PRESCRIPTION SPECTACLE LENS | Neolens, Inc. | 1988-07-29 |
| K882308 | CR-39 PLASTIC LENSES FOR EYEGLASSES | Automated Lens System | 1988-07-22 |
| K881225 | OPHTHALMIC SPECTACLE LENS BLANKS | Beta Optical Co, Inc. | 1988-04-19 |
| K875063 | SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. | Epson EL Paso, Inc. | 1988-02-22 |
| K874681 | SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES | Klockner Contract Packaging, Inc. | 1988-02-05 |
| K873245 | AR DIACOAT SINGLE VISION LENSES | Seiko Optical Products of America, Inc. | 1987-10-05 |
| K872506 | MELANITE I | Aura Lens Products | 1987-07-27 |
| K871961 | MULTIPLE SPECTACLE LENS | Korea Asahi Optical Co., Ltd. | 1987-06-03 |
| K865103 | KROM-X LENS SYSTEM | Neo Optics, Inc. | 1987-01-20 |
| K863367 | FORMALENS 2000 | Vision-Sciences, Inc. | 1986-09-26 |
| K862578 | TECHNA VISION CASTING RESIN | Techna Vision | 1986-07-23 |
Legacy Summary#
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FDA Review#
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