FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BURTON TRIAL LENS SET
K Number: K924786
·
Decision Apr 14, 1993
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
12
Applicant Total
19
Review Days
203
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
- BURTON TRIAL LENS SET
- K Number
- K924786
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1405
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R.H. Burton Co.
- Date Received
- September 23, 1992
- Decision Date
- April 14, 1993
- 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
TRIAL LENS SET
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by R.H. Burton Co.
| K Number | Device Name | ||
|---|---|---|---|
| K924773 | BURTON H- BASE TABLE - MODEL 1990 | Jun 7, 1993 | Substantially Equivalent |
| K924783 | BURTON SLIT LAMP - MODEL 850 | Apr 14, 1993 | Substantially Equivalent |
| K924774 | BURTON AUTOMATIC PROJECTOR - MODEL CP-40 | Apr 14, 1993 | Substantially Equivalent |
| K924776 | BURTON LENSMETER - MODEL 2021 | Apr 5, 1993 | Substantially Equivalent |
| K924780 | BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 | Apr 5, 1993 | Substantially Equivalent |
| K924779 | BURTON KERATOMETER - MODLE 2040 | Apr 5, 1993 | Substantially Equivalent |
| K924788 | BURTON LENSMETER | Apr 5, 1993 | Substantially Equivalent |
| K924785 | BURTON RADIUSGAUGE - MODEL 2030 | Apr 5, 1993 | Substantially Equivalent |
| K924790 | BURTON AUTO REFRACTOR - MODEL BAR-7 | Apr 5, 1993 | Substantially Equivalent |
| K924777 | BURTON APPLANATION TONOMETER - MODEL T850 & T1000 | Apr 5, 1993 | Substantially Equivalent |