FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LipiScan Dynamic Meibomian Imager
K Number: K182506
·
Decision Dec 10, 2018
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
9
Review Days
89
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Basic Information
- Device Name
- LipiScan Dynamic Meibomian Imager
- K Number
- K182506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tearscience, Inc.
- Date Received
- September 12, 2018
- Decision Date
- December 10, 2018
- Product Code
- HKI
- 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 |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Tearscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K192623 | LipiFlow Thermal Pulsation System | Oct 22, 2019 | Substantially Equivalent |
| K161357 | LipiFlow Thermal Pulsation System | Nov 4, 2016 | Substantially Equivalent |
| K152869 | LipiView II Ocular Surface Interferometer | Jan 14, 2016 | Substantially Equivalent |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | Dec 23, 2013 | Substantially Equivalent |
| K122481 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | Dec 31, 2012 | Substantially Equivalent |
| K112704 | LIPIFLOW THERMAL PULSATION SYSTEM | Dec 19, 2011 | Substantially Equivalent |
| DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) | Jun 28, 2011 | Unknown |
| K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | Oct 23, 2009 | Substantially Equivalent |