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FDA Cleared class 2 medical device,
Now approved for home use!
FDA cleared with 3 factors of improved heat treatment as compared to predicates:
1. Heated only where needed
2. A more precise temperature
3. Constant temperature over time
Over-The-Counter Use (21 CFR 801 Subpart C)
How to Clean, Fit and Use the Heated Eye Pad
INDICATION FOR USE:
The Heated Eye Pad ophthalmic warmer is a powered heating pad for the application of localized heat therapy. Use for treatment when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia.
Heated Eye Pad Introduction, what the Heated Eye Pad does for you
The Heated Eye Pad makes contact with the exterior eyelid tissue. Users typically apply the device 5-10 minutes, twice per day. Patients’ use of the Heated Eye Pad can be at home, on travel, or at the office.
A Doctor explains why choose the Heated Eye Pad over other products