Aqua Naina Sterile Saline Solution
FDA 510(k) K193441 · Chemtex USA, Inc.
510(k) numberK193441
Submission
- Device name
- Aqua Naina Sterile Saline Solution
- Applicant
- Chemtex USA, Inc.
Fairfield, NJ, US - Received
- December 11, 2019
- Decision date
- May 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPN – Accessories, Soft Lens Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
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| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 08/13/2026SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | Bausch & Lomb, Incorporated | 12/06/2022SE |
| K221263 | Aqua Naina Plus Sterile Saline SolutionLPN · Special | Chemtex USA, Inc. | 10/12/2022SE |
| K202932 | ABT12 multi-purpose solutionLPN · Traditional | Bausch & Lomb, Incorporated | 05/28/2021SE |
| K210051 | OTE MPS 045 Multi-purpose Lens Care SolutionLPN · Traditional | Ote North America, LLC | 05/26/2021SE |
| K200747 | PuriLens Plus Preservative Free SalineLPN · Traditional | The Lifestyle Company, Inc. | 05/15/2020SE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 03/02/2020SE |
| K190674 | REFRESH RELIEVA For CONTACTSLPN · Traditional | Allergan, Inc. | 08/08/2019SE |
| K191795 | AOCup Lens Case with AODiscLPN · Special | Alcon Laboratories, Inc. | 07/31/2019SE |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline SolutionLPN · Traditional | Bausch & Lomb, Incorporated | 04/11/2017SE |
More from Bausch & Lomb, Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K221263 | Aqua Naina Plus Sterile Saline SolutionLPN · Special | 10/12/2022SE |
Questions and answers
When was Aqua Naina Sterile Saline Solution cleared by the FDA?
Aqua Naina Sterile Saline Solution (K193441) received a 510(k) decision of Substantially Equivalent on May 26, 2020, 167 days after the submission was received.
What is the product code of K193441?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.