FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Corneal, Refractive
PMA: P150034
·
Decision Jun 29, 2016
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Implant, Corneal, Refractive
- Trade Name
- Raindrop Near Vision Inlay
- PMA Number
- P150034
- Device Class
- FDA Class 3
- Product Code
- LQE
- Generic Name
- Implant, corneal, refractive
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 29, 2016
- Date Received
- September 24, 2015
- Expedited Review
- N
- Docket Number
- 16M-1837
Advisory Committee Statement
Approval for the Raindrop® Near Vision Inlay. This device is indicated for intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age, who have manifest refractive spherical equivalent of (MRSE) +1.00 diopters (D) to -0.50 D with less than or equal to 0.75 D of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1.50 D to +2.50 D of reading add.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LQE | Implant, Corneal, Refractive | FDA class 3 | Unknown |