Unitox Botox Syringe
FDA 510(k) K123710 · Bio-Med USA, Inc.
510(k) numberK123710
Submission
- Device name
- Unitox Botox Syringe
- Applicant
- Bio-Med USA, Inc.
Paterson, NJ, US - Received
- December 4, 2012
- Decision date
- May 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
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Questions and answers
When was Unitox Botox Syringe cleared by the FDA?
Unitox Botox Syringe (K123710) received a 510(k) decision of Substantially Equivalent on May 9, 2013, 156 days after the submission was received.
What is the product code of K123710?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.