FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
MR Q; MR Q SUPINE; MR Q SLT
K Number: K232417
·
Decision Jan 25, 2024
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
6
Review Days
167
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Basic Information
- Device Name
- MR Q; MR Q SUPINE; MR Q SLT
- K Number
- K232417
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Meridian AG
- Date Received
- August 11, 2023
- Decision Date
- January 25, 2024
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by Meridian AG
| K Number | Device Name | ||
|---|---|---|---|
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Sep 12, 2023 | Substantially Equivalent |
| K160677 | MICRORUPTOR 6 | May 19, 2017 | Substantially Equivalent |
| K113390 | LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) | Feb 14, 2012 | Substantially Equivalent |
| K072823 | MERILAS 532A | Dec 14, 2007 | Substantially Equivalent |
| K023045 | MICRORUPTER V | Sep 26, 2002 | Substantially Equivalent |