Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting Drops
FDA 510(k) K981168 · Allergan, Inc.
510(k) numberK981168
Submission
- Device name
- Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting Drops
- Applicant
- Allergan, Inc.
Irvine, CA, US - Received
- April 1, 1998
- Decision date
- September 1, 1998
- 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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| K161457 | XEN Glaucoma Treatment SystemKYF · Traditional | 11/21/2016SE |
| K143354 | Natrelle 133 Plus Tissue ExpanderLCJ · Traditional | 08/20/2015SE |
| K123128 | Seri Surgical ScaffoldOXF · Traditional | 04/25/2013SE |
| K083812 | Refresh Optive Lens Comfort Rewetting DropsLPN · Traditional | 07/09/2009SE |
| K051852 | Single Amplifier for BotoxGWL · Traditional | 09/14/2005SE |
Questions and answers
When was Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting Drops cleared by the FDA?
Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting Drops (K981168) received a 510(k) decision of Substantially Equivalent on September 1, 1998, 153 days after the submission was received.
What is the product code of K981168?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.