510(k) K080755

Device: SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
Applicant: BAUSCH & LOMB, INC.
510(k) number: K080755
Product code: MVN
Decision: Substantially Equivalent (SESE)
Decision date: 2008-06-10
Date received: 2008-03-17
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: DEBRA KETCHUM
Address: 1400 N. Goodman St. Rochester NY US 14609 14609

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 table
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
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
K050213	FRESHLOOK ONE-DAY COLOR CONTACT LENS	Ciba Vision Corporation	2005-03-28

Legacy Summary#

summary

FDA Review#

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