FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K Number: K951292
·
Decision Jun 2, 1995
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
38
Applicant Total
34
Review Days
72
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Basic Information
- Device Name
- PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
- K Number
- K951292
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Vision Corp.
- Date Received
- March 22, 1995
- Decision Date
- June 2, 1995
- Product Code
- KYB
- 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 |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | FDA class 1 | Ophthalmic |
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|---|---|---|---|
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| K960414 | SYNERGIST POWER PACK | Apr 24, 1996 | Substantially Equivalent |
| K944993 | IOLAB.SITE CD PHACOEMULSIFICATION MODULE | Oct 12, 1995 | Substantially Equivalent |
| K944995 | IOLAB/SITE PERISTALTIC MODULE | Oct 5, 1995 | Substantially Equivalent |
| K944994 | IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE | Mar 14, 1995 | Substantially Equivalent |
| K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT | Nov 22, 1994 | Substantially Equivalent |
| K935233 | IOLAB LACRIMAL DUCT CATHETER | Sep 15, 1994 | Substantially Equivalent |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | Aug 29, 1994 | Substantially Equivalent |
| K926412 | MICRON-SCOPE II | Jul 19, 1994 | Substantially Equivalent |