Lucia
FDA 510(k) K102375 · Meridian Co., Ltd.
510(k) numberK102375
Submission
- Device name
- Lucia
- Applicant
- Meridian Co., Ltd.
Miramar, FL, US - Received
- August 20, 2010
- Decision date
- February 25, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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Questions and answers
When was Lucia cleared by the FDA?
Lucia (K102375) received a 510(k) decision of Substantially Equivalent on February 25, 2011, 189 days after the submission was received.
What is the product code of K102375?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.