Refresh Optive Lens Comfort Rewetting Drops
FDA 510(k) K083812 · Allergan, Inc.
510(k) numberK083812
Submission
- Device name
- Refresh Optive Lens Comfort Rewetting Drops
- Applicant
- Allergan, Inc.
Wilmington, MA, US - Received
- December 22, 2008
- Decision date
- July 9, 2009
- 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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Questions and answers
When was Refresh Optive Lens Comfort Rewetting Drops cleared by the FDA?
Refresh Optive Lens Comfort Rewetting Drops (K083812) received a 510(k) decision of Substantially Equivalent on July 9, 2009, 199 days after the submission was received.
What is the product code of K083812?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.