510(k) K071203
- Device
- SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
- Applicant
- OPTIKEM INTERNATIONAL, INC.
- 510(k) number
- K071203
- Product code
- LPN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-13
- Date received
- 2007-05-01
- Regulation
- 886.5928
- Classification name
- Accessories, Soft Lens Products
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN DALSING
- Address
- 2214 Sanford Dr. Unit B7 Grand Junction CO US 81505 81505
FDA Registration Numbers#
- 2522206
- 3003515967
- 9617489
- 3005010990
- 3010200303
- 3007392179
- 3003485793
- 3009446098
- 3012603529
- 9614761
- 1610287
- 3011771819
- 2011068
- 3003062331
- 3006195167
- 3003306559
- 9681630
- 1643525
- 3010607087
- 2026940
- 1937310
- 3011714173
- 1313525
- 1032500
- 3006140792
- 2249258
- 3004178847
- 3004270595
- 1719513
- 8020862
- 2335740
- 3012236936
- 3003093882
Source Documents#
Other 510(k) Records For Product Code LPN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | Bausch & Lomb, Incorporated | 2022-12-06 |
| K221263 | Aqua Naina Plus Sterile Saline Solution | Chemtex USA, Inc. | 2022-10-12 |
| K202932 | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | 2021-05-28 |
| K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | 2021-05-26 |
| K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | 2020-05-26 |
| K200747 | PuriLens Plus Preservative Free Saline | The Lifestyle Company, Inc. | 2020-05-15 |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | 2020-03-02 |
| K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | 2019-08-08 |
| K191795 | AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2019-07-31 |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | 2017-04-11 |
| K161819 | NNR06 Multi-Purpose Solution | Bausch & Lomb, Incorporated | 2016-11-25 |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2016-10-19 |
| K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | 2016-08-11 |
| K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015-08-28 |
| K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE | Alcon Laboratories, Inc. | 2015-01-26 |
Legacy Summary#
summary
FDA Review#
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