FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EYE-CEPT REWETTING DROPS
K Number: K041008
·
Decision Jul 1, 2005
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
3
Review Days
438
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
- EYE-CEPT REWETTING DROPS
- K Number
- K041008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Optics Laboratory, Inc.
- Date Received
- April 19, 2004
- Decision Date
- July 1, 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