FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTACLES LENS
K Number: K860955
·
Decision Mar 31, 1986
Classifications
1
FEI Numbers
602
Registration Numbers
602
Same Product Code
55
Applicant Total
24
Review Days
18
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
- SPECTACLES LENS
- K Number
- K860955
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Roseburg SA
- Date Received
- March 13, 1986
- Decision Date
- March 31, 1986
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQG), ordered by most recent decision date.
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
FDA 510(k)
FDA Class 1
·Ophthalmic
MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
FDA 510(k)
FDA Class 1
·Ophthalmic
NEOLENS PRESCRIPTION SPECTACLE LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
CR-39 PLASTIC LENSES FOR EYEGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Roseburg SA
| K Number | Device Name | ||
|---|---|---|---|
| K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE | Sep 1, 1994 | Substantially Equivalent |
| K890081 | CALIUS-ISABEL CANOVAS SUNGLASSES | Mar 9, 1989 | Substantially Equivalent |
| K885275 | ASSENAT-BLESCHET SUNGLASSES | Jan 24, 1989 | Substantially Equivalent |
| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | Aug 26, 1988 | Substantially Equivalent |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Dec 7, 1987 | Substantially Equivalent for Some Indications |
| K874317 | POIRIER KID-ROLLER MANUAL WHEELCHAIR | Nov 17, 1987 | Substantially Equivalent |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Jul 21, 1987 | Substantially Equivalent |
| K871688 | SPECTACLE FRAME - DANIELLE | May 29, 1987 | Substantially Equivalent |
| K871689 | SPECTACLE FRAME - LORRAINE | May 29, 1987 | Substantially Equivalent |
| K870654 | EFER ARTHROSCOPE | May 14, 1987 | Substantially Equivalent |