FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OPTISOL
K Number: K894162
·
Decision Jan 12, 1990
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
20
Applicant Total
10
Review Days
212
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Basic Information
- Device Name
- OPTISOL
- K Number
- K894162
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Chiron Ophthalmics
- Date Received
- June 14, 1989
- Decision Date
- January 12, 1990
- Product Code
- LYX
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LYX | Media, Corneal Storage | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYX), ordered by most recent decision date.
XTRA4
FDA 510(k)
FDA Unclassified
·Unknown
Cornisol
FDA 510(k)
FDA Unclassified
·Unknown
Independent Corneal Viewing Chamber (IVC-21)
FDA 510(k)
FDA Unclassified
·Unknown
Eusol-C
FDA 510(k)
FDA Unclassified
·Unknown
Cornea Cold
FDA 510(k)
FDA Unclassified
·Unknown
LIFE4C
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Chiron Ophthalmics
| K Number | Device Name | ||
|---|---|---|---|
| K915861 | MEDILENS-CS CORNEAL SHIELD | Mar 6, 1992 | Substantially Equivalent |
| K914311 | CHIROFLEX II LENS MICROSERT(TM) | Jan 27, 1992 | Substantially Equivalent |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Jun 10, 1991 | Substantially Equivalent |
| K903575 | CHIROFLEX FORCEPS | Dec 21, 1990 | Substantially Equivalent |
| K903574 | CHIROFLEX LENS MICROSERT | Sep 17, 1990 | Substantially Equivalent |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Jul 2, 1990 | Substantially Equivalent |
| K885015 | COI 72 HR COLLAGEN SHIELD | Jun 23, 1989 | Substantially Equivalent |
| K885016 | COI 24 HR COLLAGEN SHIELD | Feb 1, 1989 | Substantially Equivalent |
| K882762 | COLLAGEN SHIELD | Sep 12, 1988 | Substantially Equivalent |