FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
LE CASE HARD CONTACT LENS STORAGE CASE
K Number: K822495
·
Decision Sep 30, 1982
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
73
Applicant Total
2
Review Days
43
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Basic Information
- Device Name
- LE CASE HARD CONTACT LENS STORAGE CASE
- K Number
- K822495
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Optikem International, Inc.
- Date Received
- August 18, 1982
- Decision Date
- September 30, 1982
- Product Code
- HPX
- 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 |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPX), ordered by most recent decision date.
PMMA CLASIC
FDA 510(k)
FDA Unclassified
·Unknown
KERATOPLASTY SUTURING LENS
FDA 510(k)
FDA Unclassified
·Unknown
MULTI-VIEW BIFOCALS
FDA 510(k)
FDA Unclassified
·Unknown
MARTIN-HENSLEY SEGMENT LENS
FDA 510(k)
FDA Unclassified
·Unknown
OPTIKEM PMMA CONTACT LENS
FDA 510(k)
FDA Unclassified
·Unknown
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Optikem International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071203 | SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES | Jun 13, 2007 | Substantially Equivalent |