FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LENS, POLYCORE
K Number: K790215
·
Decision Feb 26, 1979
Classifications
1
FEI Numbers
602
Registration Numbers
602
Same Product Code
55
Applicant Total
7
Review Days
27
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Basic Information
- Device Name
- LENS, POLYCORE
- K Number
- K790215
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Polycore Optical Pte , Ltd.
- Date Received
- January 30, 1979
- Decision Date
- February 26, 1979
- Product Code
- HQG
- 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 |
|---|---|---|---|
| HQG | Lens, Spectacle, Non-Custom (Prescription) | FDA class 1 | Ophthalmic |
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Other Clearances by Polycore Optical Pte , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K832461 | POLYCORE | Aug 16, 1983 | Substantially Equivalent |
| K822542 | POLYCORE | Dec 27, 1982 | Substantially Equivalent |
| K822430 | KRYPTOX-ROUND SEGMENT BIFOCAL | Dec 27, 1982 | Substantially Equivalent |
| K822429 | SINGLE VISION POWER LENS | Dec 27, 1982 | Substantially Equivalent |
| K822431 | SUNGLASS & SAFETY PLANO LENS | Dec 27, 1982 | Substantially Equivalent |
| K822541 | VISIOPAL 75 | Dec 27, 1982 | Substantially Equivalent |