510(k) · Cleared
ClearedAlma LipoFlow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Inc. · MUU System, Suction, Lipoplasty
Cleared on Jul 14, 2017 as substantially equivalent to K150779 (Microaire Surgical Instruments, LLC, 2015) and 1 other predicate after a 78-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Jul 14, 2017
- Review
- 78 days
- Class
- Class II
- Product code
- MUU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K910696 (1991). 40 ancestors in all, the oldest K832274 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 6 generations between
- 3 generations backK101713 Lipcollector IIHuman Med AG · 2010
- 2 generations backK120328 Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012
- 1 generation backK150779 LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015
- This deviceK171242 Alma LipoFlow SystemAlma Lasers, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- 9 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- 8 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- 7 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- 6 generations backK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- 5 generations backK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- 4 generations backK083455 Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc. · 2009
- 3 generations backK101713 Lipcollector IIHuman Med AG · 2010
- 2 generations backK120328 Origins Lipoharvesting SystemSound Surgical Technologies, LLC · 2012
- 1 generation backK150779 LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC · 2015
- This deviceK171242 Alma LipoFlow SystemAlma Lasers, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| −9 | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| −8 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| −7 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| −6 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| −5 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| −4 | K083455 | Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100 | Medi-Khan USA, Inc. | 2009 | — |
| −3 | K101713 | Lipcollector II | Human Med AG | 2010 | — |
| −2 | K120328 | Origins Lipoharvesting System | Sound Surgical Technologies, LLC | 2012 | — |
| −1 | K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | Microaire Surgical Instruments, LLC | 2015 | — |
| 0 (this device) | K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUU device
- #1 K210528 IntelliFat Disposable Adipose Tissue…score 5.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic PackSummary page 4…ual Name Suction Lipoplasty System Classification 21 C.F.R. 878.5040, Class II, product code MUU Predicate Devices MicroAire LipoFilter System (K150779) (primary) MicroAire LipoTower System (K113128) Intended Use / Indications for Use The Alma LipoFlow System is u… | 2015 |
| * | K113128 | Microaire Surgical Instruments LLCSummary page 4…tion 21 C.F.R. 878.5040, Class II, product code MUU Predicate Devices MicroAire LipoFilter System (K150779) (primary) MicroAire LipoTower System (K113128) Intended Use / Indications for Use The Alma LipoFlow System is used in the aspiration, harvesting, filtering and trans… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 40 ancestors have a recall of any class.
How does its category compare?
All MUU devicesMUU System, Suction, Lipoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUU
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MUU
190in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUU
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUU
10in 2025
MAUDE reports naming product code MUU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 2 |
| 2008 | 1 | — | 0 | 4 |
| 2009 | 3 | 113 | 0 | 2 |
| 2010 | 4 | 58 | 0 | 4 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 5 | 171 | 0 | 4 |
| 2013 | 1 | — | 0 | 21 |
| 2014 | 4 | 114 | 0 | 13 |
| 2015 | 3 | 269 | 1 | 44 |
| 2016 | 1 | — | 1 | 20 |
| 2017 | 7 | 91 | 2 | 28 |
| 2018 | 1 | — | 0 | 30 |
| 2019 | 4 | 190 | 0 | 35 |
| 2020 | 2 | — | 0 | 36 |
| 2021 | 2 | — | 0 | 28 |
| 2022 | 1 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Alma LipoFlow System is used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue and infiltration for aesthetic body contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171242: Alma LipoFlow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171242
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026