510(k) · Cleared
ClearedAlma Lasers ALEX755 Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Aug 13, 2009 as substantially equivalent to K070805 (Quanta System Spa, 2007) and 9 other predicates after a 163-day review. Its family tree reaches back 7 generations to 1996. 58 later devices descend from it.
- Decided
- Aug 13, 2009
- Review
- 163 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 7 generations to K963094 (1996). 28 ancestors in all, the oldest K950019 (1995). 58 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 6 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 5 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 4 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 3 generations backK994260 Candela Gentlelase GL Dermatological LaserCandela Corp. · 2000
- 2 generations backK024335 Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003 · Recalled
- 1 generation backK032991 Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP…Light Age, Inc. · 2004
- This deviceK090571 Alma Lasers ALEX755 ModuleAlma Lasers, Ltd. · 2009
- Descendant · cites it directly · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 2 generations on · 32 of its ownK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- Descendant · 2 generations on · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- Descendant · 3 generations on · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
- Descendant · 3 generations on · 13 of its ownK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · cites it directly57descendants
- K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015 · 2 generations on32descendants
- K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc. · 2018 · 2 generations on22descendants
- K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022 · 3 generations on14descendants
- K180719InMode Diolaze SystemInmode MD, Ltd. · 2018 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −6 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −5 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −4 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −3 | K994260 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 2000 | — |
| −2 | K024335 | Candela Gentlelase Family of Laser Systems | Candela Corp. | 2003 | 1 |
| −1 | K032991 | Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX | Light Age, Inc. | 2004 | — |
| 0 (this device) | K090571 | Alma Lasers ALEX755 Module | Alma Lasers, Ltd. | 2009 | — |
| +1 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +2 | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
| +2 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| +3 | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
| +3 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 10 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (10)
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 |
|---|---|---|---|
| * | K070805 | Ultrawave II EX 1320Summary page 1…Alma Lasers ALEX755 Module Primal3 Classification Names: Laser Instrument, Surgical, Powered III. Predicate Devices : K070805 - Ultrawave II EX 1320 - Quanta System SpA : K042474 - ARION - WaveLight Laser Technologie, AG : K034030 - Cynosu… | 2007 |
| * | K042474 | ARIONSummary page 1…Classification Names: Laser Instrument, Surgical, Powered III. Predicate Devices : K070805 - Ultrawave II EX 1320 - Quanta System SpA : K042474 - ARION - WaveLight Laser Technologie, AG : K034030 - Cynosure Apogee Elite Laser - Cynosure, Inc. * K031488 - Cy… | 2004 |
| * | K034030 | Apogee EliteSummary page 1…Powered III. Predicate Devices : K070805 - Ultrawave II EX 1320 - Quanta System SpA : K042474 - ARION - WaveLight Laser Technologie, AG : K034030 - Cynosure Apogee Elite Laser - Cynosure, Inc. * K031488 - Cynosure Apogee-TKS 11 Laser - Cynosure, Inc. - K99275… | 2004 |
| * | K031488 | Cynosure Apogee-TKS II Dermatological LaserSummary page 1…ave II EX 1320 - Quanta System SpA : K042474 - ARION - WaveLight Laser Technologie, AG : K034030 - Cynosure Apogee Elite Laser - Cynosure, Inc. * K031488 - Cynosure Apogee-TKS 11 Laser - Cynosure, Inc. - K992757 - Cynosure Apogee Laser - Cynosure, Inc. * K040055 - Po… | 2003 |
| * | K992757 | Cynosure Apogee-TKS Dermatological LaserSummary page 1…eLight Laser Technologie, AG : K034030 - Cynosure Apogee Elite Laser - Cynosure, Inc. * K031488 - Cynosure Apogee-TKS 11 Laser - Cynosure, Inc. - K992757 - Cynosure Apogee Laser - Cynosure, Inc. * K040055 - Polylase LP - DDC Technologies, Inc. * K010715 - AL40 - DDC… | 2000 |
| * | K040055 | Polylase LPSummary page 1…pogee Elite Laser - Cynosure, Inc. * K031488 - Cynosure Apogee-TKS 11 Laser - Cynosure, Inc. - K992757 - Cynosure Apogee Laser - Cynosure, Inc. * K040055 - Polylase LP - DDC Technologies, Inc. * K010715 - AL40 - DDC Technologies, Inc. * K032991 - Light Age EpiCare Ae… | 2004 |
| * | K010715 | AL-40Summary page 1…nosure Apogee-TKS 11 Laser - Cynosure, Inc. - K992757 - Cynosure Apogee Laser - Cynosure, Inc. * K040055 - Polylase LP - DDC Technologies, Inc. * K010715 - AL40 - DDC Technologies, Inc. * K032991 - Light Age EpiCare Aexandrite Laser - Light Age, Inc. * K973354 - Shar… | 2001 |
| * | K032991 | Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXSummary page 1…- K992757 - Cynosure Apogee Laser - Cynosure, Inc. * K040055 - Polylase LP - DDC Technologies, Inc. * K010715 - AL40 - DDC Technologies, Inc. * K032991 - Light Age EpiCare Aexandrite Laser - Light Age, Inc. * K973354 - Sharplan EpiTouch Model 5000 Alexandrite Laser System… | 2004 |
| * | K973354 | Sharplan Epitouch Alexandrite Laser System (5000)Summary page 1…Polylase LP - DDC Technologies, Inc. * K010715 - AL40 - DDC Technologies, Inc. * K032991 - Light Age EpiCare Aexandrite Laser - Light Age, Inc. * K973354 - Sharplan EpiTouch Model 5000 Alexandrite Laser System - Sharplan Lasers, Inc. * K971874 - Sharplan EpiTouch M… | 1997 |
| * | K971874 | Sharplan Epitouch Alexandrite Laser System (5000)Summary page 1…ight Age EpiCare Aexandrite Laser - Light Age, Inc. * K973354 - Sharplan EpiTouch Model 5000 Alexandrite Laser System - Sharplan Lasers, Inc. * K971874 - Sharplan EpiTouch Model 5000 Alexandrite Laser System - Sharplan Lasers, Inc. IV. Product Description… | 1997 |
What descends from it? (58)
See all 581 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | 2014 | 57 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K140009 (Alma Lasers, Ltd., 2014) has gone furthest, with 57 descendants of its own.
- 3 other devices also cite its predicate K070805.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Alma Lasers ALEX755 Module to be used with the Harmony XLTM Multi-Application Platform is indicated for permanent hair reduction. Also indicated for the treatment of vascular lesions and benign pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090571: Alma Lasers ALEX755 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090571
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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