FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SOLARETTES
K Number: K884878
·
Decision Feb 22, 1989
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
6
Review Days
93
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Basic Information
- Device Name
- SOLARETTES
- K Number
- K884878
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Dioptics
- Date Received
- November 21, 1988
- Decision Date
- February 22, 1989
- Product Code
- HQY
- 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQY), ordered by most recent decision date.
NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
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NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
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NON-PRESCRIPTION SUNGLASSES
FDA 510(k)
FDA Class 1
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SUNGLASSES
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SUNGLASSES
FDA 510(k)
FDA Class 1
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MULTI
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Dioptics
| K Number | Device Name | ||
|---|---|---|---|
| K903487 | SOLARSHIELDS ENCORE | Nov 5, 1990 | Substantially Equivalent |
| K884877 | OCUSHIELDS MASKS | Jan 10, 1989 | Substantially Equivalent |
| K885163 | DIOPTICS EYESHIELDS | Dec 30, 1988 | Substantially Equivalent |
| K884929 | OCCUSHIELDS | Dec 15, 1988 | Substantially Equivalent |
| K862719 | SOLARSHIELDS | Aug 21, 1986 | Substantially Equivalent |