510(k) · Cleared
ClearedModel Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo, Lightpod ND: Yag Lasers, Lightp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerolase Medical Lasers, LLC · GEX Powered Laser Surgical Instrument
Cleared on Sep 17, 2012 as substantially equivalent to K033251 (Innotech USA, Inc., 2004) and 5 other predicates after a 236-day review. Its family tree reaches back 12 generations to 1995. 33 later devices descend from it.
- Decided
- Sep 17, 2012
- Review
- 236 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K943450 (1995). 192 ancestors in all, the oldest K800617 (1980). 33 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 2 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- 1 generation backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- This deviceK120235 Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag…Aerolase Medical Lasers, LLC · 2012
- Descendant · cites it directly · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- Descendant · 2 generations on · 24 of its ownK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- Descendant · 3 generations on · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- Descendant · 4 generations on · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK183156 V-LaserWontech Co., Ltd. · 2019
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 5 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 4 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 2 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- 1 generation backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- This deviceK120235 Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag…Aerolase Medical Lasers, LLC · 2012
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · cites it directly32descendants
- K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc. · 2017 · 2 generations on24descendants
- K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc. · 2018 · 3 generations on22descendants
- K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022 · 4 generations on14descendants
- K183156V-LaserWontech Co., Ltd. · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −6 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −5 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −4 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| −3 | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Ltd. | 2005 | — |
| −2 | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP… | Fotona D.D. | 2009 | — |
| −1 | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | Fotona D.D. | 2011 | — |
| 0 (this device) | K120235 | Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers… | Aerolase Medical Lasers, LLC | 2012 | — |
| +1 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| +2 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| +3 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| +4 | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
| +2 | K183156 | V-Laser | Wontech Co., Ltd. | 2019 | — |
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 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 12 | 0 |
| 1995 | 11 | 0 |
| 1996 | 18 | 0 |
| 1997 | 19 | 0 |
| 1998 | 13 | 0 |
| 1999 | 6 | 0 |
| 2000 | 15 | 0 |
| 2001 | 16 | 0 |
| 2002 | 19 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K033251 | The Friendlylight ND: Yag LasersSummary page 1…Usual Name Nd:YAG Laser Classification Name Powered, Surgical Laser Instrument (21 C.F.R. §876.4810) Predicate Devices Innotech USA- The FriendlyLight® Nd:YAG Lasers (K033251) Cutera, Inc., Cutera GenesisPlus Laser System (K103626) Incisive, Inc., PinPointe' FootLaser"' Nd:YAG Lasers (K093545, K093547)… | 2004 |
| * | K103626 | Cutera Genesisplus Laser SystemSummary page 1…rgical Laser Instrument (21 C.F.R. §876.4810) Predicate Devices Innotech USA- The FriendlyLight® Nd:YAG Lasers (K033251) Cutera, Inc., Cutera GenesisPlus Laser System (K103626) Incisive, Inc., PinPointe' FootLaser"' Nd:YAG Lasers (K093545, K093547) Fotona d.d., Fotona XP / Dynamis Nd:YAG Laser Systems (K… | 2011 |
| * | K093545 | Pinpointe Footlaser Model 6W, 30W, 100WSummary page 1…s Innotech USA- The FriendlyLight® Nd:YAG Lasers (K033251) Cutera, Inc., Cutera GenesisPlus Laser System (K103626) Incisive, Inc., PinPointe' FootLaser"' Nd:YAG Lasers (K093545, K093547) Fotona d.d., Fotona XP / Dynamis Nd:YAG Laser Systems (K090126, K101306) Intended Use / Indications for Use The Aerol… | 2010 |
| * | K093547 | Pinpointe FootlaserSummary page 1…ch USA- The FriendlyLight® Nd:YAG Lasers (K033251) Cutera, Inc., Cutera GenesisPlus Laser System (K103626) Incisive, Inc., PinPointe' FootLaser"' Nd:YAG Lasers (K093545, K093547) Fotona d.d., Fotona XP / Dynamis Nd:YAG Laser Systems (K090126, K101306) Intended Use / Indications for Use The Aerolase Nd:YA… | 2010 |
| * | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Summary page 1…Cutera GenesisPlus Laser System (K103626) Incisive, Inc., PinPointe' FootLaser"' Nd:YAG Lasers (K093545, K093547) Fotona d.d., Fotona XP / Dynamis Nd:YAG Laser Systems (K090126, K101306) Intended Use / Indications for Use The Aerolase Nd:YAG Laser is intended for use in the medical specialties of genera… | 2009 |
| * | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Summary page 1…enesisPlus Laser System (K103626) Incisive, Inc., PinPointe' FootLaser"' Nd:YAG Lasers (K093545, K093547) Fotona d.d., Fotona XP / Dynamis Nd:YAG Laser Systems (K090126, K101306) Intended Use / Indications for Use The Aerolase Nd:YAG Laser is intended for use in the medical specialties of general and pla… | 2011 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153671 | Family of CoolGlide Aesthetic Lasers | 2016 | 32 |
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 6 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 192 ancestors have a recall of any class.
- Of its descendants, K153671 (Cutera, Inc., 2016) has gone furthest, with 32 descendants of its own.
- 1 other device also cites its predicate K033251.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Aerolase Nd:YAG Laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endloscopic/laparoscopic general surgery, gastroenterology, gynecology, otolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry, and urology for surgical and aesthetic applications. Dermatology: The Aerolase Nd:YAG Laser is intended for the coagulation and hemostasis of benign vascular lesions…
Read the full statement (426 words)
The Aerolase Nd:YAG Laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endloscopic/laparoscopic general surgery, gastroenterology, gynecology, otolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry, and urology for surgical and aesthetic applications.
Dermatology:
The Aerolase Nd:YAG Laser is intended 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, spider veins and poikilodlerma of civatte; and treatment of benign cutaneous lesions, such as warts, scars, striae, debridement of dlecubitus ulcer, treatment of keloids, and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe§ au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the Aerolase Nd:YAG Laser is indicated for 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 Aerolase Nd:YAG Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The Aerolase Nd:YAG Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Aerolase Nd:YAG Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The Aerolase Nd:YAG Laser is also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Aerolase Nd:YAG Laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including:
Matrixectomy;
Periungual and subungual warts;
Plantar warts;
Radical nail excision;
Neuromas.
General Surgery:
The Aerolase Nd:YAG Laser is indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy gastroenterology, general surgery, head and neck/otolaryngology (ENT) neurosurgery, oculaplastics, orthopedics, plastic surgery; pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia), podiatry and urology. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120235: Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo, Lightpod ND: Yag Lasers, Lightp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120235
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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