510(k) Report

510(k) · Cleared

Cleared

Adept 1064/532 Laser

K032220510(k) TraditionalCleared Oct 24, 200395-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

Adept Medical Concepts · GEX Powered Laser Surgical Instrument

Cleared on Oct 24, 2003 as substantially equivalent to K020697 (Depilase Group, Ltd., 2002) and 11 other predicates after a 95-day review. Its family tree reaches back 7 generations to 1992. 126 later devices descend from it.

Decided
Oct 24, 2003
Review
95 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
12

Its longest line of descent runs back 7 generations to K910422 (1992). 94 ancestors in all, the oldest K820106 (1982). 126 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 12 other ancestors2001: 12 other ancestors2000: 9 other ancestors1999: 4 other ancestors1998: 6 other ancestors1997: 9 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 ancestor2004: 1 descendant cleared2006: 1 descendant cleared2005: 1 descendant cleared2017: 5 descendants cleared2009: 2 descendants cleared2020: 6 descendants cleared2010: 3 descendants cleared2013: 9 descendants cleared2014: 5 descendants cleared2015: 5 descendants cleared2011: 4 descendants cleared2024: 15 descendants cleared2022: 7 descendants cleared2016: 8 descendants cleared2026: 8 descendants cleared2018: 4 descendants cleared2019: 4 descendants cleared2023: 6 descendants cleared2025: 28 descendants cleared2021: 3 descendants cleared2012: 1 descendant 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 33 other ancestors3 generations back: 15 other ancestors4 generations back: 11 other ancestors5 generations back: 4 other ancestors6 generations back: 14 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 29 descendants5 generations forward: 36 descendants6 generations forward: 20 descendants7 generations forward: 7 descendants8 generations forward: 9 descendants9 generations forward: 6 descendants10 generations forward: 3 descendants11 generations forward: 1 descendant K022226 · 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 · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
  3. 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
  4. 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
  5. 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
  6. 2 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  7. 1 generation backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  8. This deviceK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
  9. Descendant · cites it directly · 73 of its ownK062369 Iridex Oculight TXIridex Corp · 2006
  10. Descendant · 2 generations on · 72 of its ownK091534 Lightlas Model 532Lightmed Corp. · 2009
  11. Descendant · 3 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
  12. Descendant · cites it directly · 51 of its ownK040384 Mydon CWavelight Laser Technologie AG · 2004
  13. Descendant · 4 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010

Showing 5 of 126 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12009: 22010: 32011: 42012: 12013: 92014: 52015: 52016: 82017: 52018: 42019: 42020: 62021: 32022: 72023: 62024: 152025: 282026: 8
2004high 28 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 126 · See all
  • K062369Iridex Oculight TXIridex Corp · 2006 · cites it directly73descendants
  • K091534Lightlas Model 532Lightmed Corp. · 2009 · 2 generations on72descendants
  • K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 3 generations on68descendants
  • K040384Mydon CWavelight Laser Technologie AG · 2004 · cites it directly51descendants
  • K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 4 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K910422Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc.1992—
−6K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.1996—
−5K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.1997—
−4K974536Photoderm HR SystemEsc Medical Systems, Ltd.1998—
−3K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.2000—
−2K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
−1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
0 (this device)K032220Adept 1064/532 LaserAdept Medical Concepts2003—
+1K062369Iridex Oculight TXIridex Corp2006—
+2K091534Lightlas Model 532Lightmed Corp.2009—
+3K100558Quanta Diode Laser SystemQuanta System Spa2010—
+1K040384Mydon CWavelight Laser Technologie AG2004—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198810
199010
199140
199350
199480
199560
199680
199790
199860
199940
200090
2001120
2002120
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200920
201030
201140
201210
201390
201450
201550
201680
201750
201840
201940
202060
202130
202270
202360
2024150
2025280
202680
FIG. 1 — Lineage of K032220, 1992–2026Source: 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? (12)

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
*K020697Depilase Twin Yag Laser System
Summary page 1
…Class I1 medical device; (21 CFR 878.4810) Product Code: GEX Panel: 79 Predicate devices: The Depilase Twin YAG Laser (K020697); Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K98 1798);…
Depilase Group, Ltd.2002—
*K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002—
*K003202Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II
Summary page 1
…X Panel: 79 Predicate devices: The Depilase Twin YAG Laser (K020697); Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K98 1798); Laserscope Lyra Surgical Laser System (K990903, K003765, KO03 147,…
Altus Medical2001—
*K023954Altus Medical Coolglide Laser Systems and Accessories
Summary page 1
…Panel: 79 Predicate devices: The Depilase Twin YAG Laser (K020697); Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K98 1798); Laserscope Lyra Surgical Laser System (K990903, K003765, KO03 147,…
Altus Medical, Inc.2003—
*K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…
Summary page 1
…Panel: 79 Predicate devices: The Depilase Twin YAG Laser (K020697); Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K98 1798); Laserscope Lyra Surgical Laser System (K990903, K003765, KO03 147, KO 1…
Altus Medical, Inc.2002—
*K991798Acme Medical Aesthetic ND:Yag Laser
Our reading of the summary gave K981798, FDA’s number for Lactosorb Pop Rivet (Biomet, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Altus Family CoolGlide Aesthetic Lasers”.
Altus Medical2000—
*K990903Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)
Summary page 1
…s Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K98 1798); Laserscope Lyra Surgical Laser System (K990903, K003765, KO03 147, KO 10284, KO 10834, K020021). Device description: The Adept 1064/532 is a long pulse…
Laserscope1999—
*K003765Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)
Summary page 1
…CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K98 1798); Laserscope Lyra Surgical Laser System (K990903, K003765, KO03 147, KO 10284, KO 10834, K020021). Device description: The Adept 1064/532 is a long pulse Nd:YAG la…
Laserscope2001—
*K003147Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration)Laserscope2000—
*K010284Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Laserscope20013
*K010834Lyra Series Surgical Laser System & AccessoriesLaserscope2001—
*K020021Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)
Summary page 1
…003202, K023954, K022226, K98 1798); Laserscope Lyra Surgical Laser System (K990903, K003765, KO03 147, KO 10284, KO 10834, K020021). Device description: The Adept 1064/532 is a long pulse Nd:YAG laser which emits its energy at 1064 nm or 5…
Laserscope2002—

Also cleared against K020697: 2 other devices →

What descends from it? (126)

See all 126

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

NumberDeviceApplicantDecidedDescendants
K062369Iridex Oculight TXIridex Corp200673
K040384Mydon CWavelight Laser Technologie AG200451

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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 3 of the 94 ancestors have a recall of any class.
  • Of its descendants, K062369 (Iridex Corp, 2006) has gone furthest, with 73 descendants of its own.
  • 2 other devices also cite its predicate K020697.

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.

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?

The Adept 1064/532 Laser is indicated for coagulation and haemostasis of vascular lesions (1064 and 532 im wavelengths) and removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types (1064 nm wavelength). Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen. 1064 nm wavelength General Surgical Applications: For the incision…

Read the full statement (978 words)

The Adept 1064/532 Laser is indicated for coagulation and haemostasis of vascular lesions (1064 and 532 im wavelengths) and removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types (1064 nm wavelength). Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

1064 nm wavelength

General Surgical Applications:

For the 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:

For photocoagulation 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. In addition, the Adept 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 Adept 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.

Cutting, incision, excision, hemostasis, coagulation, vaporization, and ablation of soft tissue in dermatology and plastic surgery.

The Adept Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.

The Adept Laser 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 for pseudofolliculitis barbae (PFB).

The Adept Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The Adept Laser is indicated for use on all skin types (Fitzpatrick I - IV) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types (1064 nm wavelength).

Endoscopic/laparoscopic Surgery:

The Adept Laser is indicated for use in a variety of surgical procedures in several surgical specialties. These include, but are not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.

General Surgery:

For incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.

Gynecology:

For the treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.

Head and Neck/-Otorhinolaryngology (ENT):

For tissue incision, excision, ablation, and vessel hemostasis.

Hemostasis During Surgery:

For adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.

Neurosurgery:

For hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs, glioblastoma, astrocytoma, oligodendroglioma.

Oculoplastics:

For incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents.

Pulmonary Surgery:

For palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

Thoracic Surgery:

For cutting (incisiodexcision), 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, incisiodexcision, debulking, and ablation of lung tissue (thoracoscopy).

Urology:

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

Orthopedics:

For cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.

532 nm wavelength

The Adept 1064/532 Laser is intended for the coagulation and hemostasis of vascular lesions (1064 and 532 nm wavelengths).

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 extremities 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 Neck Otorhinolaryngology (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 (incisiodexcision), coagulating, and vaporizing 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, incisiodexcision, 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).

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K032220: Adept 1064/532 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032220

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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