BEAR 2 Body
FDA 510(k) K232242 · Foreo, Inc.
510(k) numberK232242
Submission
- Device name
- BEAR 2 Body
- Applicant
- Foreo, Inc.
Las Vegas, NV, US - Received
- July 28, 2023
- Decision date
- May 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K200803 | BEAR and BEAR miniNFO · Traditional | 07/31/2020SE |
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Questions and answers
When was BEAR 2 Body cleared by the FDA?
BEAR 2 Body (K232242) received a 510(k) decision of Substantially Equivalent on May 13, 2024, 290 days after the submission was received.
What is the product code of K232242?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.