FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISULAS yag
K Number: K230350
·
Decision Sep 22, 2023
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
29
Review Days
225
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Basic Information
- Device Name
- VISULAS yag
- K Number
- K230350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, Inc.
- Date Received
- February 9, 2023
- Decision Date
- September 22, 2023
- 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 Carl Zeiss Meditec, Inc.
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|---|---|---|---|
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| K222200 | CIRRUS HD-OCT | Apr 13, 2023 | Substantially Equivalent |
| K191194 | CLARUS | Jun 25, 2019 | Substantially Equivalent |
| K181534 | CIRRUS HD-OCT | Feb 15, 2019 | Substantially Equivalent |
| K181444 | CLARUS | Jan 10, 2019 | Substantially Equivalent |
| K182318 | Retina Workplace | Oct 24, 2018 | Substantially Equivalent |
| K173371 | VisuMax Femtosecond Laser | Apr 13, 2018 | Substantially Equivalent |
| K161194 | PLEX Elite 9000 SS-OCT | Oct 26, 2016 | Substantially Equivalent |