510(k) · Cleared
ClearedModified Alma Lasers Harmony 1064NM (ND:Yag) Modules
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Inc. · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Cleared on Mar 8, 2012 as substantially equivalent to K103626 (Cutera, Inc., 2011) and 4 other predicates after a 76-day review. Its family tree reaches back 15 generations to 1995. 34 later devices descend from it.
- Decided
- Mar 8, 2012
- Review
- 76 days
- Class
- Class II
- Product code
- PDZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K943450 (1995). 275 ancestors in all, the oldest K800617 (1980). 34 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK113810 Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012
- Descendant · cites it directly · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 2 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 3 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
- Descendant · 4 generations on · 18 of its ownK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- Descendant · 5 generations on · 13 of its ownK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK113810 Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K133837Viora V-TotalViora, Ltd. · 2014 · cites it directly33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 2 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · 3 generations on31descendants
- K153568InMode Plus SystemInmode MD, Ltd. · 2016 · 4 generations on18descendants
- K172302InMode PLUS SystemInmode MD, Ltd. · 2017 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules | Alma Lasers, Inc. | 2012 | — |
| +1 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +2 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +3 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| +4 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| +5 | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 7 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 15 | 0 |
| 1995 | 13 | 0 |
| 1996 | 19 | 0 |
| 1997 | 22 | 0 |
| 1998 | 19 | 0 |
| 1999 | 11 | 0 |
| 2000 | 24 | 0 |
| 2001 | 26 | 0 |
| 2002 | 30 | 0 |
| 2003 | 21 | 0 |
| 2004 | 13 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 PDZ? 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 PDZ device
- #1 K253960 Medicell Mycosis Laser (MCML24004)score 11.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K103626 | Cutera Genesisplus Laser SystemSummary page 1…accessories) e Product Code(s): GEX ' ¢ Regulation(s): US Title 21 Part 878.4810 118 Predicate Devices e Cutera GenesisPlus Laser System, manufactured by Cutera, Inc. (K103626) ¢ PinPointe™ FootLaser™, manufactured by PinPointe USA, Inc. (K093547). e PinPointe™ FootLaser™ (Model 6W, 30W, 100W), manufactu… | 2011 |
| * | K093547 | Pinpointe FootlaserSummary page 1…t 878.4810 118 Predicate Devices e Cutera GenesisPlus Laser System, manufactured by Cutera, Inc. (K103626) ¢ PinPointe™ FootLaser™, manufactured by PinPointe USA, Inc. (K093547). e PinPointe™ FootLaser™ (Model 6W, 30W, 100W), manufactured by Incisive, Inc. (K093545) Q-Clear™ Nd:YAG Laser, manufacmred by L… | 2010 |
| * | K093545 | Pinpointe Footlaser Model 6W, 30W, 100WSummary page 1…ra, Inc. (K103626) ¢ PinPointe™ FootLaser™, manufactured by PinPointe USA, Inc. (K093547). e PinPointe™ FootLaser™ (Model 6W, 30W, 100W), manufactured by Incisive, Inc. (K093545) Q-Clear™ Nd:YAG Laser, manufacmred by Light Age, Inc. (K110370) Alma Lasers Harmony XL™ Muli-Application Platform, manufactured… | 2010 |
| * | K110370 | Q-ClearSummary page 1…ointe USA, Inc. (K093547). e PinPointe™ FootLaser™ (Model 6W, 30W, 100W), manufactured by Incisive, Inc. (K093545) Q-Clear™ Nd:YAG Laser, manufacmred by Light Age, Inc. (K110370) Alma Lasers Harmony XL™ Muli-Application Platform, manufactured by Alma Lasers (K072564) IV. Product Description The Modifie… | 2011 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 1…Incisive, Inc. (K093545) Q-Clear™ Nd:YAG Laser, manufacmred by Light Age, Inc. (K110370) Alma Lasers Harmony XL™ Muli-Application Platform, manufactured by Alma Lasers (K072564) IV. Product Description The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for use in podiatry and for the temporary in… | 2008 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133837 | Viora V-Total | 2014 | 33 |
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 17 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 10 of the 275 ancestors have a recall of any class.
- Of its descendants, K133837 (Viora, Ltd., 2014) has gone furthest, with 33 descendants of its own.
- 6 other devices also cite its predicate K103626.
How does its category compare?
All PDZ devicesPDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · PDZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PDZ
196in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDZ
No recall names PDZ since 2007.
Adverse event reports per year · PDZ
1in 2019
MAUDE reports naming product code PDZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 205 | 0 | 0 |
| 2012 | 6 | 196 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Multi-Application Platform for use in aesthetic, cosmetic, 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, endoscopic/laparoscopic general surgery, gastroenterology, gynecology…
Read the full statement (439 words)
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Multi-Application Platform for use in aesthetic, cosmetic, 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, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, podiatry, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) used with the Harmony XL™ Multi-Application Platform are indicated for use in:
Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
Matrixectomy
Periungual and subungual warts
Plantar warts
Radical nail excision
Neuromas
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) are intended for use with the Harmony XL™ Multi-Application Platform for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of.
Benign vascular lesions such as, but not limited to treatment of:
Port wine stains
Hemangiomas
Warts
Superficial and deep telangiectasias (venulectasias)
Reticular veins (0.1-4.0 mm dia.) of the leg
Rosacea
Venus lake
Leg veins
Spider veins
Poikiloderma of Civatte
Angiomas
Benign cutaneous lesions, such as, but not limited to:
Warts
Scars
Striae
Psoriasis
Benign pigmented lesions such as, but not limited to:
Lentigos (age spots)
Solar lentigos (sun spots)
Cafe-au-lait macules
Seborrheic keratoses
Nevi and nevus of Ota
Chloasma
Verrucae
Skin tags
Keratoses
The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos).
Plaques
Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but not limited to:
Periocular wrinkles
Perioral wrinkles
Laser skin resurfacing procedures for the treatment of:
Acne scars
Wrinkles
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The 1064 nm Nd:YAG lasers (Long Pulsed only, with and without contact-cooling) is indicated for:
Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
Removal or lightening of unwanted hair (with and without adjuvant preparation)
Treatment of pseudofolliculitis barbae (PFB)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113810: Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113810
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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