FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIOPTICS EYESHIELDS
K Number: K885163
·
Decision Dec 30, 1988
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
6
Review Days
17
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Basic Information
- Device Name
- DIOPTICS EYESHIELDS
- K Number
- K885163
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Dioptics
- Date Received
- December 13, 1988
- Decision Date
- December 30, 1988
- Product Code
- HOY
- 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 |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
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Other Clearances by Dioptics
| K Number | Device Name | ||
|---|---|---|---|
| K903487 | SOLARSHIELDS ENCORE | Nov 5, 1990 | Substantially Equivalent |
| K884878 | SOLARETTES | Feb 22, 1989 | Substantially Equivalent |
| K884877 | OCUSHIELDS MASKS | Jan 10, 1989 | Substantially Equivalent |
| K884929 | OCCUSHIELDS | Dec 15, 1988 | Substantially Equivalent |
| K862719 | SOLARSHIELDS | Aug 21, 1986 | Substantially Equivalent |