FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RGP MULTI-PURPOSE SOLUTION ID 100136
K Number: K000148
·
Decision Apr 11, 2000
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
32
Applicant Total
47
Review Days
84
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
- RGP MULTI-PURPOSE SOLUTION ID 100136
- K Number
- K000148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5918
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon Laboratories
- Date Received
- January 18, 2000
- Decision Date
- April 11, 2000
- Product Code
- MRC
- 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 |
|---|---|---|---|
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRC), ordered by most recent decision date.
cleadew GP hydra one
FDA 510(k)
FDA Class 2
·Ophthalmic
Boston One Step Liquid Enzymatic Cleaner
FDA 510(k)
FDA Class 2
·Ophthalmic
VibrantVue Scleral Saline
FDA 510(k)
FDA Class 2
·Ophthalmic
MaxiTears Contacts PF
FDA 510(k)
FDA Class 2
·Ophthalmic
Nutrifill
FDA 510(k)
FDA Class 2
·Ophthalmic
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Alcon Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K062624 | NEXT GENERATION LASER | Nov 5, 2007 | Substantially Equivalent |
| K062865 | SMALL VOLUME SYRINGE | Aug 23, 2007 | Substantially Equivalent |
| K984573 | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP | Sep 16, 1999 | Substantially Equivalent |
| K990480 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER | May 10, 1999 | Substantially Equivalent |
| K984575 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Jan 14, 1999 | Substantially Equivalent |
| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Dec 18, 1998 | Substantially Equivalent |
| K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Dec 18, 1998 | Substantially Equivalent |
| K981561 | LIQUID ENZYME ID 90133 | Jul 24, 1998 | Substantially Equivalent |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Jul 9, 1998 | Substantially Equivalent |
| K981103 | TURBOSONICS LIMITED REUSE ULTRASONIC TIP | Jun 23, 1998 | Substantially Equivalent |