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#
- 3016856167
- 3031552721
- 3003392070
- 3030510804
- 3043152400
- 1000253285
- 1000158117
- 3004116534
- 8020477
- 9616939
- 3007123980
- 3009233789
- 3003951061
- 3003433048
- 3005785090
- 3017069344
- 3007558052
- 3031235934
- 3030184056
- 1000428458
- 3008370976
- 3027556697
- 3003344414
- 3013532963
- 3012065550
- 3038320371
- 3030732538
- 3011321733
- 3012379423
- 3016671478
- 3031590635
- 3042193309
- 9615466
- 8040195
- 3006356447
- 3003845599
- 3010502837
- 3006494408
- 3011248235
- 3010119835
- 3013953125
- 3021244189
- 3023320949
- 3016929296
- 3003748653
- 8022792
- 8030271
- 3014020412
- 3012842398
- 3038281008
- 3007084588
- 9617805
- 3011898560
- 3044736402
- 3015140362
- 3009831516
- 9710450
- 9680346
- 2020853
- 3031656500
- 3014329429
- 3010606175
- 1000240191
- 3011447477
- 3014167550
- 3038284246
- 3015531880
- 3004134915
- 3008345156
- 3011532790
- 3015168599
- 3003639769
- 3005391450
- 3038134334
- 3017905900
- 9681818
- 3021612330
- 3031710707
- 9614827
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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