FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TBD
K Number: K120214
·
Decision Jun 8, 2012
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
14
Review Days
136
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Basic Information
- Device Name
- TBD
- K Number
- K120214
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lensar, Inc.
- Date Received
- January 24, 2012
- Decision Date
- June 8, 2012
- Product Code
- OOE
- 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 |
|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | FDA class 2 | Ophthalmic |
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Other Clearances by Lensar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220259 | ALLY Adaptive Cataract Treatment System | Jun 9, 2022 | Substantially Equivalent |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Dec 21, 2018 | Substantially Equivalent |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Aug 9, 2018 | Substantially Equivalent |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Mar 2, 2018 | Substantially Equivalent |
| K171337 | LENSAR Laser System fs 3D (LLS-fs 3D) | Aug 10, 2017 | Substantially Equivalent |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | May 5, 2017 | Substantially Equivalent |
| K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Oct 15, 2015 | Substantially Equivalent |
| K143010 | LENSAR Laser System - fs 3D | Mar 20, 2015 | Substantially Equivalent |
| K123859 | TBD | Mar 27, 2013 | Substantially Equivalent |
| K122829 | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | Dec 3, 2012 | Substantially Equivalent |