FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LENS PLUS REWETTING DROPS
K Number: K042562
·
Decision Jul 29, 2005
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
8
Review Days
311
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LENS PLUS REWETTING DROPS
- K Number
- K042562
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Medical Optics, Inc.
- Date Received
- September 21, 2004
- Decision Date
- July 29, 2005
- Product Code
- LPN
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPN), ordered by most recent decision date.
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
FDA 510(k)
FDA Class 2
·Ophthalmic
Aqua Naina Plus Sterile Saline Solution
FDA 510(k)
FDA Class 2
·Ophthalmic
ABT12 multi-purpose solution
FDA 510(k)
FDA Class 2
·Ophthalmic
OTE MPS 045 Multi-purpose Lens Care Solution
FDA 510(k)
FDA Class 2
·Ophthalmic
Aqua Naina Sterile Saline Solution
FDA 510(k)
FDA Class 2
·Ophthalmic
PuriLens Plus Preservative Free Saline
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Advanced Medical Optics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081681 | VITRECTOMY CUTTER AND ACCESSORIES | Oct 8, 2008 | Substantially Equivalent |
| K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | Oct 2, 2008 | Substantially Equivalent |
| K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | Apr 7, 2006 | Substantially Equivalent |
| K050648 | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK | Apr 5, 2005 | Substantially Equivalent |
| K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS | Oct 19, 2004 | Substantially Equivalent |
| K032030 | BLINK CL LUBRICANT EYE DROPS | Sep 25, 2003 | Substantially Equivalent |
| K030092 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Apr 4, 2003 | Substantially Equivalent |