FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FRAMES (SPECTACLES)
K Number: K914239
·
Decision Dec 16, 1991
Classifications
1
FEI Numbers
1086
Registration Numbers
1086
Same Product Code
197
Applicant Total
2
Review Days
89
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
- FRAMES (SPECTACLES)
- K Number
- K914239
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5842
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jane Fui Optical Co., Ltd.
- Date Received
- September 18, 1991
- Decision Date
- December 16, 1991
- Product Code
- HQZ
- 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 |
|---|---|---|---|
| HQZ | Frame, Spectacle | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQZ), ordered by most recent decision date.
VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
FDA 510(k)
FDA Class 1
·Ophthalmic
SPECTACLE FRAME
FDA 510(k)
FDA Class 1
·Ophthalmic
SPECTACLE FRAME OR EYEGLASS FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
SPECTACLE FRAME
FDA 510(k)
FDA Class 1
·Ophthalmic
OPTICAL FRAMES
FDA 510(k)
FDA Class 1
·Ophthalmic
FRAME, SPECTACLES
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Jane Fui Optical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K962279 | ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES | Aug 26, 1996 | Substantially Equivalent |