FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAUSCH & LOMB WETTING AND SOAKING SOLUTION
K Number: K980133
·
Decision Mar 11, 1998
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
23
Review Days
55
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
- BAUSCH & LOMB WETTING AND SOAKING SOLUTION
- K Number
- K980133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymer Technology Corp.
- Date Received
- January 15, 1998
- Decision Date
- March 11, 1998
- 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 Polymer Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K011945 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION | Sep 12, 2001 | Substantially Equivalent |
| K974466 | BOSTON ADVANCE CLEANER | Feb 19, 1998 | Substantially Equivalent |
| K973217 | BOSTON LIQUID ENZYMATIC CLEANER | Nov 24, 1997 | Substantially Equivalent |
| K970698 | BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS | May 6, 1997 | Substantially Equivalent |
| K951552 | BOSTON CONTACT LENS CASE | Jun 26, 1995 | Substantially Equivalent |
| K943177 | BOSTON(R) 7 - 30(ENFLUFOCON A) | Aug 25, 1994 | Substantially Equivalent |
| K942365 | BOSTON VII | Jun 23, 1994 | Substantially Equivalent |
| K923438 | BOSTON CONDITIONING SOLUTION | Dec 28, 1992 | Substantially Equivalent |
| K923587 | GLUCOSE TEST SYSTEM | Dec 28, 1992 | Substantially Equivalent |
| K923437 | BOSTON CLEANER II | Oct 28, 1992 | Substantially Equivalent |