Lapex BCS
FDA 510(k) K081962 · Meridian Co., Ltd.
510(k) numberK081962
Submission
- Device name
- Lapex BCS
- Applicant
- Meridian Co., Ltd.
Deer Field, IL, US - Received
- July 9, 2008
- Decision date
- December 29, 2008
- 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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| K034009 | Lapex 2000NHN · Abbreviated | 01/21/2005SE |
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Questions and answers
When was Lapex BCS cleared by the FDA?
Lapex BCS (K081962) received a 510(k) decision of Substantially Equivalent on December 29, 2008, 173 days after the submission was received.
What is the product code of K081962?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.