FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
K Number: K912112
·
Decision Jun 17, 1991
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
9
Review Days
35
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
- PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
- K Number
- K912112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tomey Corporation USA
- Date Received
- May 13, 1991
- Decision Date
- June 17, 1991
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQJ), ordered by most recent decision date.
Katalyst Cyclophotocoagulation Probe
FDA 510(k)
FDA Class 2
·Ophthalmic
SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR
FDA 510(k)
FDA Class 2
·Ophthalmic
TROKEL /3 GONIO LASER LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
SHIELDS T.C. LASER LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
MQL 20 ND:YAG OPHTHALMIC LASER
FDA 510(k)
FDA Class 2
·Ophthalmic
INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Tomey Corporation USA
| K Number | Device Name | ||
|---|---|---|---|
| K971953 | CONFOSCAN | Aug 14, 1997 | Substantially Equivalent |
| K971685 | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM | Jun 24, 1997 | Substantially Equivalent |
| K961805 | TOMEY DTL ELECTRODE | May 9, 1997 | Substantially Equivalent |
| K932571 | TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 | Aug 31, 1995 | Substantially Equivalent |
| K945959 | VIDEO VISION ANALYZER (VIVA), VRB 100 | Mar 1, 1995 | Substantially Equivalent |
| K944910 | TOMEY EM-1000 SPECULAR MICROSCOPE | Nov 22, 1994 | Substantially Equivalent |
| K924760 | TOMEY PROTON TONOMETER | Apr 5, 1993 | Substantially Equivalent |
| K921815 | TOMEY PE-300 PORTABLE ERG | Jul 15, 1992 | Substantially Equivalent |