Raindrop Near Vision Inlay
FDA premarket approval P150034 · decided 2016-06-29
Approval details
- PMA number
- P150034
- Trade name
- Raindrop Near Vision Inlay
- Generic name
- Implant, corneal, refractive
- Applicant
- Rvo 2.0, Inc. (D.B.A. Optics Medical)
- Date received
- 2015-09-24
- Decision date
- 2016-06-29
- Days to decision
- 279 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- 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.
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