Lipokit with Disposable 50CC Aft Syringe
FDA 510(k) K121703 · Medi-Khan USA, Inc.
510(k) numberK121703
Submission
- Device name
- Lipokit with Disposable 50CC Aft Syringe
- Applicant
- Medi-Khan USA, Inc.
Boston, MA, US - Received
- June 8, 2012
- Decision date
- December 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUU – System, Suction, Lipoplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5040
- Specialty
- General, Plastic Surgery
See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).
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| K191564 | Progenikine Concentrating System 25 mL SystemMUU · Traditional | Emcyte Corporation | 11/07/2019SE |
| K190386 | KTA Adipose Treatment KitMUU · Traditional | Stemics S.A.S | 10/10/2019SE |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123)MUU · Traditional | Auragen Aesthetics, LLC | 05/03/2019SE |
| K172717 | Automatic Tissue Processing UnitMUU · Traditional | Bsl Co. | 05/25/2018SE |
More from Bsl Co.
| 510(k) | Device | Decision |
|---|---|---|
| K083455 | Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100MUU · Traditional | 05/18/2009SE |
Questions and answers
When was Lipokit with Disposable 50CC Aft Syringe cleared by the FDA?
Lipokit with Disposable 50CC Aft Syringe (K121703) received a 510(k) decision of Substantially Equivalent on December 7, 2012, 182 days after the submission was received.
What is the product code of K121703?
The FDA product code is MUU – System, Suction, Lipoplasty, a Class II (moderate risk) device regulated under 21 CFR 878.5040.