510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Ultrawave Iii EX 1320

K083207510(k) TraditionalCleared Nov 14, 200814-day reviewClass II21 CFR 878.4810Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Quanta System Spa · GEX Powered Laser Surgical Instrument

Cleared on Nov 14, 2008 as substantially equivalent to K070805 (Quanta System Spa, 2007) and 1 other predicate after a 14-day review. Its family tree reaches back 8 generations to 1992. 96 later devices descend from it. It has been recalled once.

Decided
Nov 14, 2008
Review
14 days
Class
Class II
Product code
GEX
Recalls
1
Predicates
2

Its longest line of descent runs back 8 generations to K910422 (1992). 101 ancestors in all, the oldest K820106 (1982). 96 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2003: 1 other ancestor2002: 13 other ancestors2001: 12 other ancestors2000: 11 other ancestors1999: 5 other ancestors1998: 6 other ancestors1997: 10 other ancestors1996: 8 other ancestors1994: 8 other ancestors1995: 6 other ancestors1990: 1 other ancestor1993: 5 other ancestors1991: 4 other ancestors1988: 1 other ancestor1982: 1 other ancestor2012: 1 descendant cleared2014: 1 descendant cleared2013: 2 descendants cleared2015: 4 descendants cleared2022: 15 descendants cleared2019: 5 descendants cleared2020: 10 descendants cleared2018: 5 descendants cleared2023: 7 descendants cleared2016: 2 descendants cleared2026: 10 descendants cleared2024: 12 descendants cleared2021: 3 descendants cleared2017: 5 descendants cleared2025: 14 descendants clearedK910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000×2: 2 generations cleared close together, K014040 (2002), K022226 (2002) K032218 · Adept 1064/532/755 Laser · Adept Medical Concepts · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 14 other ancestors3 generations back: 37 other ancestors4 generations back: 13 other ancestors5 generations back: 10 other ancestors6 generations back: 4 other ancestors7 generations back: 14 other ancestors 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 18 descendants4 generations forward: 24 descendants5 generations forward: 13 descendants6 generations forward: 3 descendants7 generations forward: 8 descendants8 generations forward: 4 descendants9 generations forward: 10 descendants10 generations forward: 4 descendants K032218 · Adept 1064/532/755 Laser · Adept Medical Concepts · 2003K022226 · Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models · Altus Medical, Inc. · 2002K014040 · Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models · Altus Medical, Inc. · 2002K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992−50+5+10
  1. Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
  3. 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
  4. 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
  5. 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
  6. 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  7. 2 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  8. 1 generation backK032218 Adept 1064/532/755 LaserAdept Medical Concepts · 2003
  9. This deviceK083207 Ultrawave Iii EX 1320Quanta System Spa · 2008
  10. Descendant · cites it directly · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
  11. Descendant · cites it directly · 40 of its ownK123168 Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · Recalled
  12. Descendant · cites it directly · 38 of its ownK130256 MDK Multi-Applications PlatformQuanta System Spa · 2013
  13. Descendant · 2 generations on · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
  14. Descendant · 3 generations on · 36 of its ownK160368 EVO platformQuanta System Spa · 2016

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22014: 12015: 42016: 22017: 52018: 52019: 52020: 102021: 32022: 152023: 72024: 122025: 142026: 10
2012high 15 (2022) · low 1 (2012)2026

Most influential descendants

Showing 5 of 96 · See all
  • K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · cites it directly57descendants
  • K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · cites it directly40descendants
  • K130256MDK Multi-Applications PlatformQuanta System Spa · 2013 · cites it directly38descendants
  • K152012EVO platformQuanta System Spa · 2015 · 2 generations on37descendants
  • K160368EVO platformQuanta System Spa · 2016 · 3 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K910422Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc.1992—
−7K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.1996—
−6K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.1997—
−5K974536Photoderm HR SystemEsc Medical Systems, Ltd.1998—
−4K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.2000—
−3K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
−2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
−1K032218Adept 1064/532/755 LaserAdept Medical Concepts2003—
0 (this device)K083207Ultrawave Iii EX 1320Quanta System Spa2008—
+1K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.2014—
+1K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa20121
+1K130256MDK Multi-Applications PlatformQuanta System Spa2013—
+2K152012EVO platformQuanta System Spa2015—
+3K160368EVO platformQuanta System Spa2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198810
199010
199140
199350
199480
199560
199680
1997100
199860
199950
2000110
2001120
2002130
200310
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201410
201540
201620
201750
201850
201950
2020100
202130
2022150
202370
2024120
2025140
2026100
FIG. 1 — Lineage of K083207, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K070805Ultrawave II EX 1320
Summary page 1
…tion Instrument, surgical, powered, laser Name: Predicate Devices: . Quanta System S.p.A ULTRAWAVE IT EX 1320 (K070805) aAdept Medical Concept 1064/5321755 Laser (K032218) Inte…
Quanta System Spa20071
*K032218Adept 1064/532/755 Laser
Summary page 1
…E IT EX 1320 (K070805) aAdept Medical Concept 1064/5321755 Laser (K032218) Intended Use I Device Name: Ultrawave III EX 1320 Indications for Use:…
Adept Medical Concepts2003—

Also cleared against K070805: 3 other devices →

What descends from it? (96)

See all 96

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457
K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa201240
K130256MDK Multi-Applications PlatformQuanta System Spa201338

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 7, 2012Class IIZ-0693-2013Labeling False and MisleadingQuanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
  • 4 of the 101 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 devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

Nd:YAG 1064nm Intended for general surgical applications; dermatology/plastic surgery; endoscopic/laparoscopic surgery; general surgery; gynecology; ENT; hemostasis; neurosurgery; oculoplastics; pulmonary surgery; thoracic surgery; urology; and orthopedics. General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery…

Read the full statement (874 words)

Nd:YAG 1064nm

Intended for general surgical applications; dermatology/plastic surgery; endoscopic/laparoscopic surgery; general surgery; gynecology; ENT; hemostasis; neurosurgery; oculoplastics; pulmonary surgery; thoracic surgery; urology; and orthopedics.

General Surgical Applications:

Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/-otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery and urology.

Dermatology/Plastic Surgery:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins and poikiloderma of Civatte and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. It addition, the laser is 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 blue and/or black tattoos), and plaques.

The laser is also 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 laser is also indicated for the treatment of facial wrinkles.

It is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).

It is indicated for the reduction of red pigmentation in hypertrophic .nd keloid scars where vascularity is an integral part of the scar.

It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

Orthopedics:

Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and artbroscopic applications.

Pulmonary Surgery:

Palliative treatment of benign and malignant pulmonary airway obtructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

Thoracic Surgery:

Incision, excision, coagulating and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).

Urology:

All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminate).

Nd:YAG 1320nm

Indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles, fine lines and wrinkles, and the treatment of back acne and atrophic acne Sears.

Nd:YAG 532nm

For the coagulation and hemostasis of vascular lesions.

Dermatology/Plastic Surgery:

For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins] : benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size.

General Surgery:

Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft Tissue as well as in Endoscopic (e.g., laparoscopic) or open surgeries.

Gastroenterology:

Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Esophagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric Erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).

Head and NecMOtorhinolaryngology (ENT):

Tissue incision, excision, ablation, and vessel hemostasis

Hemostasis during Surgery:

Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery.

Neurosurgery:

Hemostasis for: Pituitary Tumor, Meningioma; hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.

Ophthalmology:

Post-vitrectomy endophotocoagulation of the retina.

Pulmonary Surgery:

Palliative treatment of benign and malignant pulmonary airway obstructions, including Squamous Cell Carcinoma, Adenocarcinoma; Carcinoid; Benign Tumors; Granulomas; Benign Strictures.

Thoracic Surgery:

Cutting (incision and excision), coagulating, and vaporizing of soft tissue Thoracic applications including, but not limited to: Isolation of vessels for endartecetomy and/or by-pass grafts, Wedge Resections, Thoractoniy, Formation of Pacemaker pockets. Vaporization, coagulation, incision and excision, debulking, and ablation of lung tissue (Thoracoscopy)

Urology:

All applications including: Superficial urinary bladder tumors, invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).

Alexandrite 755nm

Intended for coagulation and hemostatis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin types. Also indicated for pigmented lesions and wrinkles.

IPL

590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair reduction.

550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion ( i.e.,face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

400-1200nm

Indicated for inflammatory acne (acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece 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 fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

Any other different use is considered incorrect.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K083207: Ultrawave Iii EX 1320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083207

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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