510(k) · Cleared
ClearedAlma Q
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 Jun 15, 2017 as substantially equivalent to K040384 (Wavelight Laser Technologie AG, 2004) and 2 other predicates after an 85-day review. Its family tree reaches back 9 generations to 1992. 2 later devices descend from it.
- Decided
- Jun 15, 2017
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 101 ancestors in all, the oldest K820106 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 2 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 1 generation backK040384 Mydon CWavelight Laser Technologie AG · 2004
- This deviceK170850 Alma QAlma Lasers, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK233024 Alma HarmonyAlma Lasers, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK252561 BTL-754FFBTL Industries, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 2 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 1 generation backK040384 Mydon CWavelight Laser Technologie AG · 2004
- This deviceK170850 Alma QAlma Lasers, Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −2 | K032220 | Adept 1064/532 Laser | Adept Medical Concepts | 2003 | — |
| −1 | K040384 | Mydon C | Wavelight Laser Technologie AG | 2004 | — |
| 0 (this device) | K170850 | Alma Q | Alma Lasers, Ltd. | 2017 | — |
| +1 | K233024 | Alma Harmony | Alma Lasers, Inc. | 2024 | — |
| +2 | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 14 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K040384 | Mydon CSummary page 5…Accessories III. Predicate Devices [21 CFR 807.92(a) (3)] 510(k) # Trade Name Product Code K040384 Mydon/Quantel Derma GEX K032667 Naturalase/Focus Medical GEX… | 2004 |
| * | K032667 | Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow)Summary page 5…(a) (3)] 510(k) # Trade Name Product Code K040384 Mydon/Quantel Derma GEX K032667 Naturalase/Focus Medical GEX K992597 Naturalase/Focus Medical GEX… | 2004 |
| * | K992597 | Lorad LT-100 Laser Treatment SystemSummary page 5…Product Code K040384 Mydon/Quantel Derma GEX K032667 Naturalase/Focus Medical GEX K992597 Naturalase/Focus Medical GEX IV. Device Description [21 CFR 807.92(a) (4)] The… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233024 | Alma Harmony | 2024 | 1 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 101 ancestors have a recall of any class.
- Of its descendants, K233024 (Alma Lasers, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K040384.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Q laser is intended for use in aesthetic and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery. LP1064nm 1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg…
Read the full statement (291 words)
The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.
LP1064nm
1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
2. The Alma Q laser system is also indicated for the treatment of wrinkles.
3. The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
4. The Alma Q laser system is indicated for use on all skin types (Fitzpatrick VI), including tanned skin.
5. The intended use of the integral cooling system in the Alma Q laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
QS 532nm
1. Tattoo removal
-Red inks
-Blue and light blue inks
-Green inks
2. Treatment of benign vascular lesions
-Telangiectasias
-Spider angiomas
-Cherry angiomas
-Spider nevi
3. Treatment of benign pigmented lesions
-Cafe-au-lait birthmarks
-Solar lentigines
-Becker's nevi
-Freckles
-Nevus spilus
-Nevus of ota
4. Incision, excision, ablation, and vaporization of soft tissue in general dermatology
QS 1064nm
The Alma Q laser treatment system is intended for use:
For the removal or lightening of unwanted facial or body hair.
For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery,
Benign dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170850: Alma Q.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170850
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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