510(k) Report

510(k) · Cleared

Cleared

Lipocontrol

K090754510(k) TraditionalCleared Jan 21, 2011672-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Osyris Medical · ORK Laser Assisted Lipolysis

Cleared on Jan 21, 2011 as substantially equivalent to K073617 (Osyris, 2008) and 3 other predicates after a 672-day review. Its family tree reaches back 6 generations to 2001.

Decided
Jan 21, 2011
Review
672 days
Class
Class II
Product code
ORK
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K010329 (2001). 11 ancestors in all, the oldest K002258 (2000). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors2002: 1 other ancestor2006: 1 other ancestor2000: 1 other ancestorK010329 · LOGIQ 500 · General Electric Co. · 2001K032182 · GE Logiq 7, Model 2354858 · General Electric Co. · 2003K041813 · GE Logiq 7 Ultrasound BT04 · Ge Medical Systems Ultrasound and Primary Care Dia · 2004K052441 · GE Logiq 7 Ultrasound BT05 · General Electric Co. · 2005K073408 · GE Logiq BT08 Diagnostic Ultrasound System · Ge Medical Systems Ultrasound and Primary Care Dia · 2007K082185 · GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 · Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · recalled2000200220042006200820102012
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors K082185 · GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 · Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · recalledK073408 · GE Logiq BT08 Diagnostic Ultrasound System · Ge Medical Systems Ultrasound and Primary Care Dia · 2007K052441 · GE Logiq 7 Ultrasound BT05 · General Electric Co. · 2005K041813 · GE Logiq 7 Ultrasound BT04 · Ge Medical Systems Ultrasound and Primary Care Dia · 2004K032182 · GE Logiq 7, Model 2354858 · General Electric Co. · 2003K010329 · LOGIQ 500 · General Electric Co. · 2001−50
  1. Root · 6 generations backK010329 LOGIQ 500General Electric Co. · 2001
  2. 5 generations backK032182 GE Logiq 7, Model 2354858General Electric Co. · 2003
  3. 4 generations backK041813 GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 2004
  4. 3 generations backK052441 GE Logiq 7 Ultrasound BT05General Electric Co. · 2005
  5. 2 generations backK073408 GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007
  6. 1 generation backK082185 GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · Recalled
  7. This deviceK090754 LipocontrolOsyris Medical · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K010329LOGIQ 500General Electric Co.2001—
−5K032182GE Logiq 7, Model 2354858General Electric Co.2003—
−4K041813GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia2004—
−3K052441GE Logiq 7 Ultrasound BT05General Electric Co.2005—
−2K073408GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia2007—
−1K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia20081
0 (this device)K090754LipocontrolOsyris Medical2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200610
200820
FIG. 1 — Lineage of K090754, 2001–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 ORK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K073617Pharaon Lipo
Summary page 1
…878.4810 Device panel General & Plastic Surgery PHARAON LIPO manufactured by OSYRIS MEDICAL and cleared as K073617 SMARTLIPO MPX laser with SMARTSENSE manufactured Legally marketed by CYNOSURE and cleared as K083379 p…
Osyris2008—
*K083379Cynosure Smartlipo MPX Laser with Smartsense C Module
Summary page 1
…ICAL and cleared as K073617 SMARTLIPO MPX laser with SMARTSENSE manufactured Legally marketed by CYNOSURE and cleared as K083379 predicate devices GE logic E9, manufactured by GE Healthcare and cleared as K082185…
Cynosure, Inc.2008—
*K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2
Summary page 1
…nufactured Legally marketed by CYNOSURE and cleared as K083379 predicate devices GE logic E9, manufactured by GE Healthcare and cleared as K082185 CTG 2000sa, manufactured by ULTRAGUIDE and cleared as K022354 O…
Ge Medical Systems Ultrasound and Primary Care Dia20081
*K022354Ultraguide CTG 2000SA
Summary page 1
…ufactured by GE Healthcare and cleared as K082185 CTG 2000sa, manufactured by ULTRAGUIDE and cleared as K022354 OSYRIS Medical Submitter 60, avenue Halley 59650 VILLENEUVE D'ASCQ FRANCE…
Ultraguide, Ltd.2002—

Also cleared against K073617: 6 other devices →

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 10 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • 6 other devices also cite its predicate K073617.

How does its category compare?

All ORK devices

ORK Laser Assisted Lipolysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · ORK

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ORK

Too few ORK 510(k)s in any year since 2007 to give a median.

Recalls per year · ORK

No recall names ORK since 2007.

Adverse event reports per year · ORK

1in 2024

2018: 22024: 1
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code ORK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

LIPOCONTROL is indicated for:

Laser assisted lipolysis

Indications for use as stated in the FDA summary.

Also cleared against K073617

6 other devices cite the same predicate.

  • K110375Blueshine's Gold SeriesBlueshine Srl · 2012
  • K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family Naturalase NL810Focus Medical, LLC · 2010
  • K091800Lipoeze Laser Assisted Aspiration CannulaCurve Medical · 2009
  • K083478SmoothlipoEleme Medical, Inc. · 2009
  • K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 20081 recall
  • K082004Smoothkit+Osyris · 2008

https://510kreport.com/device/K090754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090754: Lipocontrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090754

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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