510(k) K993252
- Device
- METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
- Applicant
- COOPERVISION, INC.
- 510(k) number
- K993252
- Product code
- MVN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-24
- Date received
- 1999-09-28
- Regulation
- 886.5925
- Classification name
- Lens, Contact, (disposable)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BONNIE TSYMBAL
- Address
- 711 N. Rd. Scottsville, NY US 14546 14546
FDA Registration Numbers#
- 3026035637
- 3014054090
- 3006405660
- 3004146030
- 3031092085
- 3002732585
- 3006946962
- 3025414414
- 3017889743
- 3015533540
- 3003365815
- 1053053
- 3009518015
- 3010640396
- 3009633067
- 9680540
- 9617710
- 9614154
- 3008034930
- 3017069344
- 2032112
- 9710495
- 3010890435
- 3005395964
- 3004585750
- 3024762292
- 3043022738
- 3012719596
- 1610287
- 3011771819
- 3014768085
- 3016009612
- 2024119
- 3015700153
- 3012760082
- 3012918760
- 3011521050
- 1313525
- 3030261726
- 3033524682
- 3018616050
- 3006297986
- 3013576528
- 3012138439
- 3015282628
- 3009076545
- 1057985
- 3011649033
- 3004529384
- 3010392968
- 3041165456
- 3036689755
- 3030421258
- 3007064560
- 3015146121
- 3022375855
- 3005184723
- 3030262618
- 3003981983
- 3010364480
- 3008504746
- 3011989923
- 3012123291
- 3035385765
- 3021632375
- 3012862899
- 3006015326
- 3013170070
- 3015393207
- 3039590526
- 9614392
- 9610813
- 1314956
- 9614761
- 3015430860
- 1123818
- 3003515967
- 3011553378
- 3006514242
Source Documents#
Other 510(k) Records For Product Code MVN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. | 2020-09-22 |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. | 2020-08-21 |
| K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear | Yung Sheng Optical Co., Ltd. | 2015-06-15 |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | 2015-01-16 |
| K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | Sauflon Pharmaceuticals, Ltd. | 2013-07-26 |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | Bausch & Lomb, Inc. | 2011-10-25 |
| K080632 | CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS | Clearlab SG Pte, Ltd. | 2008-10-15 |
| K080755 | SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | 2008-06-10 |
| K073060 | CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Innova Vision, Inc. | 2007-11-29 |
| K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | CooperVision, Inc. | 2006-11-22 |
| K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb | 2006-06-22 |
| K052832 | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES | Sauflon Pharmaceuticals, Ltd. | 2006-05-15 |
| K053191 | DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS | Innova Vision, Inc. | 2006-05-12 |
| K051900 | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR | Johnson & Johnson Vision Care, Inc. | 2005-08-12 |
| K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | Ciba Vision Corporation | 2005-05-27 |
Legacy Summary#
summary
FDA Review#
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