510(k) K130805
- Device
- MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
- Applicant
- MENICON CO. LTD.
- 510(k) number
- K130805
- Product code
- MRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-07-03
- Date received
- 2013-03-25
- Regulation
- 886.5918
- Classification name
- Products, Contact Lens Care, Rigid Gas Permeable
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ellen M Beucler
- Address
- 187 Ballardvale St., Suite 180 Wilmington MA US 01887 01887
FDA Registration Numbers#
- 3003779166
- 2249258
- 1032500
- 8020862
- 3003515967
- 3003306559
- 3004178847
- 2011068
- 1315522
- 3007177643
- 3038161965
- 3003093882
- 1313525
- 2026940
- 3010200303
- 9617489
- 3004270595
- 3006195167
- 3016440358
- 2335740
- 9614761
- 3003062331
- 3010607087
- 1610287
- 3016114779
Source Documents#
Other 510(k) Records For Product Code MRC #
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| K251876 | cleadew GP hydra one | Ophtecs Corporation | 2025-10-09 |
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| K201069 | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | 2020-07-31 |
| K182984 | MaxiTears Contacts PF | Omnivision AG | 2019-07-24 |
| K181566 | Nutrifill | Contamac, Ltd. | 2018-10-22 |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | 2018-08-10 |
| K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution | Bausch and Lomb, Incorporated | 2018-03-27 |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | Bausch & Lomb, Incorporated | 2017-11-27 |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | 2017-11-16 |
| K122273 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | 2013-01-02 |
| K082855 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Menicon Co, Ltd. | 2010-03-09 |
| K052074 | JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING, | Szabocsik and Associates | 2005-09-01 |
| K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS | Advanced Medical Optics, Inc. | 2004-10-19 |
| K024289 | BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION | Bausch & Lomb, Incorporated | 2003-05-02 |
| K023455 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | 2003-02-28 |
Legacy Summary#
summary
FDA Review#
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