FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TALIA LASER SLIT
K Number: K930518
·
Decision Jan 25, 1994
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
6
Review Days
358
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Basic Information
- Device Name
- TALIA LASER SLIT
- K Number
- K930518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Talia Technology , Ltd.
- Date Received
- February 1, 1993
- Decision Date
- January 25, 1994
- Product Code
- HJO
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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|---|---|---|---|
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Aug 23, 2006 | Substantially Equivalent |
| K041290 | RTA MODEL D RETINAL THICKNESS ANALYZER | May 24, 2004 | Substantially Equivalent |
| K031312 | RTA MODEL D RETINAL THICKNESS ANALYZER | May 6, 2003 | Substantially Equivalent |
| K000731 | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER | Mar 31, 2000 | Substantially Equivalent |
| K964137 | RTA RETINAL THICKNESS ANALYZER | Feb 3, 1997 | Substantially Equivalent |