Product code MML— Ophthalmic
Altomed Malhotra Platinum Segments
- Classification name
- Weights, Eyelid, External
- Device class
- Class 2
- Regulation
- 21 CFR 886.5700
- Advisory panel
- Ophthalmic
- Total cleared
- 14
- First cleared
- Most recent
FDA classification definition
“Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)”
Market context for product code MML
FDA has cleared devices under product code MML between 1994 and 2017, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2017
- 2015
- 2003
- 2001
- 2000
- 1999
- 1997
- 1994
Top applicants under product code MML
Recent clearances under product code MML
- K170591 — Altomed Malhotra Platinum Segments
- K150986 — Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
- 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
- K001123 — KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
- K994289 — SUTUREGROOVE
- K000127 — KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
- K990224 — LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
- K983607 — LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
- K971242 — BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
- K971245 — BLINK EXTERNAL EYELID WEIGHT
- K940974 — EYECLOSE EXTERNAL EYELID WEIGHTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.