Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants— 510(k) K150986
Substantially EquivalentMeddev Corporation
FDA 510(k) clearance K150986 for Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants, Substantially Equivalent on 2015-08-17. Applicant: Meddev Corporation. Device class: 2.
Clearance details
- Applicant
- Meddev Corporation
- Product code
- Code MML
- Device class
- Class 2
- Regulation
- 21 CFR 886.5700
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code MML
view all- K170591 — Altomed Malhotra Platinum Segments
- K021750 — LID CHAIN EYELID WEIGHTS
- K011740 — CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
- K011115 — KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
- K003646 — SUTUREGROOVE WEIGHT SIZING SET
Recalls naming K150986
K-number listed on FDA's recall record- Z-1744-2025 — Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
- Z-1745-2025 — Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150986.
Data sourced from openFDA. This site is unofficial and independent of the FDA.