510(k) · Cleared
ClearedOlive Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ama Network, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 14, 2016 as substantially equivalent to K123483 (Beijing Syntech Laser CO., LTD., 2013) after an 87-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Oct 14, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K910422 (1992). 60 ancestors in all, the oldest K871179 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- 2 generations backK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- 1 generation backK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- This deviceK161981 Olive PlusAma Network, Inc. · 2016
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 7 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 6 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 5 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 4 generations backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- 3 generations backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- 2 generations backK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- 1 generation backK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- This deviceK161981 Olive PlusAma Network, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −7 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −6 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −5 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −4 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| −3 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| −2 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| −1 | K123483 | Diode Laser | Beijing Syntech Laser CO., LTD. | 2013 | — |
| 0 (this device) | K161981 | Olive Plus | Ama Network, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K123483 | Diode LaserSummary page 4…ion Panel : General and Plastic Surgery. Product Code : GEX type : Traditional 4. Legally marketed Predicate Device K123483 Diode Laser DLH-06 Beijing Syntech Laser Olive Plus Diode Laser system has same characteristics s… | 2013 |
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 24 years and passes through 10 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 60 ancestors have a recall of any class.
- 5 other devices also cite its predicate K123483.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin
Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6, 9,and 12 months after the completion of a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161981 · printed Nov 3, 2026
Cite this page
510(k) Report. “K161981: Olive Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K161981
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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