FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRIA LENS SET
K Number: K843095
·
Decision Oct 5, 1984
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
12
Applicant Total
3
Review Days
59
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
- TRIA LENS SET
- K Number
- K843095
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1405
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Optek Medico Co., Ltd.
- Date Received
- August 7, 1984
- Decision Date
- October 5, 1984
- Product Code
- HPC
- 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 |
|---|---|---|---|
| HPC | Set, Lens, Trial, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPC), ordered by most recent decision date.
BOBES LENS SET
FDA 510(k)
FDA Class 1
·Ophthalmic
OTI MODEL TLS-60
FDA 510(k)
FDA Class 1
·Ophthalmic
OPHTHALMIC TRIAL LENSES
FDA 510(k)
FDA Class 1
·Ophthalmic
CONTACT LENSES
FDA 510(k)
FDA Class 1
·Ophthalmic
MARCO TRIAL SETS
FDA 510(k)
FDA Class 1
·Ophthalmic
BURTON TRIAL LENS SET
FDA 510(k)
FDA Class 1
·Ophthalmic