STARS2000 Power Cannula
FDA 510(k) K012236 · Kmi Kolster Methods, Inc.
510(k) numberK012236
Submission
- Device name
- STARS2000 Power Cannula
- Applicant
- Kmi Kolster Methods, Inc.
Anaheim, CA, US - Received
- July 17, 2001
- Decision date
- November 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- QPB – System, Suction, Lipoplasty For Removal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5040
- Specialty
- General, Plastic Surgery
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
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|---|---|---|---|
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| K251944 | Lipocosm Harmonic SystemQPB · Traditional | Lipocosm, LLC | 06/08/2026SE |
| K253396 | AYON Body Contouring System (AYON SYSTEM)QPB · Traditional | Apyx Medical Corporation | 05/08/2026SE |
| K252495 | Lssa (NP-200)QPB · Traditional | Newpong Co., Ltd. | 04/03/2026SE |
| K244050 | AYON Body Contouring System (AYON SYSTEM)QPB · Traditional | Apyx Medical Corporation | 05/12/2025SE |
| K244026 | PAL 7020 ConsoleQPB · Traditional | Microaire Surgical Instruments, LLC | 04/25/2025SE |
| K242804 | PAL Aspiration SystemQPB · Traditional | Microaire Surgical Instruments, LLC | 12/30/2024SE |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS)QPB · Traditional | Cellmyx | 11/27/2024SE |
| K240188 | Vitruvian LiposaberQPB · Traditional | Black & Black Surgical, Inc. | 09/13/2024SE |
More from Black & Black Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060414 | Kolster Methods, Inc., Featherlift Silhouette SutureGAW · Traditional | 10/23/2006SE |
| K043591 | Featherlift Extended Aptos ThreadGAW · Traditional | 03/04/2005SE |
| K010702 | Xub External UltrasoundIMI · Traditional | 08/09/2001SE |
| K002859 | Ssw-Sterile Solution WarmerLHC · Traditional | 11/16/2000SE |
| K991203 | Irrigation or Infusion Pump K PumpFRN · Traditional | 10/15/1999SE |
Questions and answers
When was STARS2000 Power Cannula cleared by the FDA?
STARS2000 Power Cannula (K012236) received a 510(k) decision of Substantially Equivalent on November 19, 2001, 125 days after the submission was received.
What is the product code of K012236?
The FDA product code is QPB – System, Suction, Lipoplasty For Removal, a Class II (moderate risk) device regulated under 21 CFR 878.5040.