FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1
K Number: K871245
·
Decision May 7, 1987
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
34
Review Days
41
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Basic Information
- Device Name
- LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1
- K Number
- K871245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Chiron Vision Corp.
- Date Received
- March 27, 1987
- Decision Date
- May 7, 1987
- Product Code
- LQJ
- 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 |
|---|---|---|---|
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | FDA class 2 | Ophthalmic |
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| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Jun 2, 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 |
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