Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
FDA 510(k) clearance K150986 · decided 2015-08-17
Clearance details
- K-number
- K150986
- Device name
- Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
- Applicant
- Meddev Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-04-14
- Decision date
- 2015-08-17
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- MML
- Device class
- 2
- Regulation number
- 886.5700
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 recall (Z-1744-2025) | Meddev Corp | 2025-05-09 |
| Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 recall (Z-1745-2025) | Meddev Corp | 2025-05-09 |