FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONTACT LENS LOUPE, INSPETION LOUPE
K Number: K852054
·
Decision Sep 5, 1985
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
1
Applicant Total
6
Review Days
119
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
- CONTACT LENS LOUPE, INSPETION LOUPE
- K Number
- K852054
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1420
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Ascon Medical Instruments, Ltd.
- Date Received
- May 9, 1985
- Decision Date
- September 5, 1985
- Product Code
- HLN
- 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 |
|---|---|---|---|
| HLN | Gauge, Lens, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HLN), ordered by most recent decision date.
View allOther Clearances by Ascon Medical Instruments, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K852055 | ASCON OPHTHALMIC SPONGE | Sep 4, 1985 | Substantially Equivalent |
| K852548 | ATL 225 MW TRAIL LENS SET | Jul 31, 1985 | Substantially Equivalent |
| K852057 | ASCON SURGICAL INSTRUMENTS | Jun 27, 1985 | Substantially Equivalent |
| K852056 | ACC CROSS CYLINDERS | Jun 5, 1985 | Substantially Equivalent |
| K852126 | ATF 101 TRAIL FRAME | Jun 5, 1985 | Substantially Equivalent |