510(k) Report

510(k) · Cleared

Cleared

Diode Medical Laser Family, Models 4, 6, 30

K072034510(k) TraditionalCleared Sep 20, 200757-day reviewClass II21 CFR 878.4810

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 Sep 20, 2007 as substantially equivalent to K042211 (Surgical Laser Technologies, Inc., 2004) and 4 other predicates after a 57-day review. Its family tree reaches back 14 generations to 1995. 263 later devices descend from it.

Decided
Sep 20, 2007
Review
57 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
5

Its longest line of descent runs back 14 generations to K943450 (1995). 169 ancestors in all, the oldest K800617 (1980). 263 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2004: 8 other ancestors2002: 17 other ancestors2005: 5 other ancestors2003: 13 other ancestors2001: 13 other ancestors2000: 13 other ancestors1998: 9 other ancestors1995: 12 other ancestors1999: 6 other ancestors1997: 18 other ancestors1996: 15 other ancestors1993: 6 other ancestors1985: 1 other ancestor1980: 1 other ancestor1994: 9 other ancestors1990: 1 other ancestor1989: 1 other ancestor1992: 3 other ancestors1991: 3 other ancestors2012: 6 descendants cleared2009: 2 descendants cleared2008: 4 descendants cleared2010: 7 descendants cleared2023: 17 descendants cleared2011: 5 descendants cleared2013: 10 descendants cleared2020: 19 descendants cleared2014: 9 descendants cleared2015: 13 descendants cleared2022: 24 descendants cleared2016: 11 descendants cleared2024: 28 descendants cleared2026: 21 descendants cleared2018: 13 descendants cleared2025: 43 descendants cleared2019: 9 descendants cleared2017: 10 descendants cleared2021: 12 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 21 other ancestors3 generations back: 16 other ancestors4 generations back: 30 other ancestors5 generations back: 31 other ancestors6 generations back: 21 other ancestors7 generations back: 27 other ancestors8 generations back: 3 other ancestors9 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 33 descendants3 generations forward: 46 descendants4 generations forward: 48 descendants5 generations forward: 56 descendants6 generations forward: 45 descendants7 generations forward: 24 descendants8 generations forward: 4 descendants K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−10−50+5
  1. Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 10 generations between
  3. 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  4. 2 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  5. 1 generation backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  6. This deviceK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
  7. Descendant · cites it directly · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
  8. Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  9. Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  10. Descendant · cites it directly · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
  11. Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Show all 14 generations
  1. Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 2 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 1 generation backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. This deviceK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007

Showing 5 of 263 descendants. See all descendants

Descendants cleared per year

2008: 42009: 22010: 72011: 52012: 62013: 102014: 92015: 132016: 112017: 102018: 132019: 92020: 192021: 122022: 242023: 172024: 282025: 432026: 21
2008high 43 (2025) · low 2 (2009)2026

Most influential descendants

Showing 5 of 263 · See all
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · cites it directly192descendants
  • K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
  • K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
  • K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · cites it directly68descendants
  • K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 4 generations on62descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−13K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−12K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−11K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−10K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−9K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−8K000944Thermage Thermacool SystemThermage, Inc.2000—
−7K013034Modification to: Thermacool IiaThermage, Inc.2001—
−6K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−5K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−4K030142Thermacool TC SystemThermage, Inc.2003—
−3K031671Polaris WRSyneron Medical, Ltd.2003—
−2K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−1K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
0 (this device)K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007—
+1K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—
+2K101916Joule Multi-Platform SystemSciton, Inc2011—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.2014—
+1K100558Quanta Diode Laser SystemQuanta System Spa2010—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
198910
199010
199130
199230
199360
199490
1995120
1996150
1997180
199890
199960
2000130
2001130
2002170
2003130
200480
200550
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200840
200920
201070
201150
201260
2013100
201490
2015130
2016110
2017100
2018130
201990
2020190
2021120
2022240
2023170
2024280
2025430
2026210
FIG. 1 — Lineage of K072034, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems
Summary page 1
…GEX 21 C.F.R. 878.4810 Predicate Devices: PhotoMedex, Inc.'s LaserPro Surgical Diode Laser System (K04221 1) *Diomed, Inc. EVLT Kit and DPlus Lasers (K04 1957)…
Surgical Laser Technologies, Inc.2004—
*K041957Evlt Kit and the D15PLUS and D30PLUS Diode Lasers
Summary page 1
…o Surgical Diode Laser System (K04221 1) *Diomed, Inc. EVLT Kit and DPlus Lasers (K04 1957) *BioLase Technology, Inc EZLase Dental Diode Laser system (K06 1898)…
Diomed, Inc.20041
*K061898Ezlase
Summary page 1
…Plus Lasers (K04 1957) *BioLase Technology, Inc EZLase Dental Diode Laser system (K06 1898) *INTERmiedic Arfran, S.A. INTERinedic Diode Laser Family (K053540)…
Biolase Technology, Inc.2007—
*K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…
Summary page 1
…Laser system (K06 1898) *INTERmiedic Arfran, S.A. INTERinedic Diode Laser Family (K053540) *Dornier MedTech America, Inc Dornier Diode Laser Family (K020339) In…
Intermedic Arfran, SA2006—
*K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…
Summary page 1
…Laser Family (K053540) *Dornier MedTech America, Inc Dornier Diode Laser Family (K020339) Intended Use/ 808 rim, 940 nm, 980nm Wavelengths Indications for Use: The Quanta System Diode Medical Lasers Family,…
Dornier Medtech America, Inc.2002—

Also cleared against K042211: 2 other devices →

What descends from it? (263)

See all 263

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

NumberDeviceApplicantDecidedDescendants
K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192
K100558Quanta Diode Laser SystemQuanta System Spa201068
K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054
K090762LEDAQuantel Derma GmbH200946
K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834
K110375Blueshine's Gold SeriesBlueshine Srl20124
K082445CURATIVE980 Diode LaserOroscience, Inc.20080

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 12 years and passes through 5 companies; a new generation was cleared every 10 months on median.
  • 7 of the 169 ancestors have a recall of any class.
  • Of its descendants, K083613 (Quanta System Spa, 2008) has gone furthest, with 192 descendants of its own.
  • 2 other devices also cite its predicate K042211.

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. 2007, 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?

808 nm, 940 nm, 980 nm Wavelengths The Quanta System Diode Medical Lasers Family, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT)…

Read the full statement (1,198 words)

808 nm, 940 nm, 980 nm Wavelengths

The Quanta System Diode Medical Lasers Family, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The Quanta System Diode Medical Lasers Family are indicated for use in the performance of specific surgical applications in gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery as follows:

Gastroenterology (Medical 30)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy.

Neurosurgery (Medical 30.6)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex.

General Surgery (Medical 30)

Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy: cholecystectomy; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma: thyroidectomy; thoracotomy; cavernous hemangioma.

Genitourinary (Urology) (Medical 30)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia

Thoracic Surgery (Medical 30)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectomy; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection; hemostasis; thoracotomy.

Gvnecology (GYN) (Medical 30)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) : procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA): myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum.

Pulmonology (Medical 30)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.

Ophthalmology (Medical 30)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endo-nasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty.

Orthopedics (Medical 30

The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures, Applications include: Open: Dissect and coagulate.

Otolaryngology (ENT) (Medical 30)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages: ethmoidectomy; meatal antrostomy; Laryngo-tracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy.

In addition, at 808nm and 980nm wavelengths, the Quanta system Diode Medical Laser family is intended for the following use:

Urology (Medical 30):

Lesions of external genitalia; Circumcision; Condyloma; Bladder tumors; Bladder neck incisions; Vaporization of the prostate

Neurosurgery (Medical 30):

Percutaneous Disc Decompression; Discectomy; Hemostasis in conjunction with meningiomas

Arthroscopy (Medical 30):

Chondromalacia; Synovectomy; Menisectomy

Pulmonary Surgery (Medical 30):

Endoscopic pulmonary applications; Tracheal bronchial lesions; Benign and malignant pulmonary or stricture

Cardiac Surgery (Medical 30):

Coagulation and haemostasis of cardiac tissue

Dermatology/Aesthetics (Medical30):

Photocoagulation of vascular & dermatological lesions of the face and extremities; Photocoagulation of telangiectasia, veinulectasias of the legs and face; Treatment of reticular veins and branch varicosities; Pyogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas; Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Chery angioma, Hemangioma, Port wine stains, angiokeratoma, and benign ipidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.; Dermatology surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcomn. Warty leucoplasy and ulcers debridmnent; Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne treatment; Hair removal of unwanted hair from skin type IV;

Plastic Surgery (Medical 30):

Cut, coagulation & vaporization; Blepharoplasy

Vascular Surgery (Medical 30):

Endoluminal or endovenus laser surgery for saphenous incompetent veins.

Dental applications (Medical 30. 6. 4):

Frenectomy; Frenotomy; Biopsy; Pulpotorny as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening

808 rnm Wavelength

The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Quanta System Diode Medical Laser Family are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

940nm Wavelength

The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in endlovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

The Quanta System Diode Medical Laser Family (Medical 30), is intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endloscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non contact open surgery (with or without a handpiece).

It (Medical 30) is also intended for use in the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.

It (Medical 30) is also indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.

The Quanta System Diode Laser Family (Medical 30, 6. 4) is also indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:Excisional and incisional biopsiesExposure of unerupted teeth; Fibroma removal; Frenectomy; Frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingivoplasty; Gingival incision and excision; Haemostasis and coagulation; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomny; Pulpotomy as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty

The Quanta System Diode Laser Family (Medical 30. 6, 4) _is also indicated for Laser Periodontal procedures, including: Laser soft tissue curettage; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K072034: Diode Medical Laser Family, Models 4, 6, 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072034

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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