510(k) Report

510(k) · Cleared

Cleared

Adept 1064/755 Laser

K032221510(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 K020412 (Depilase Group, Ltd., 2002) and 15 other predicates after a 95-day review. Its family tree reaches back 7 generations to 1992.

Decided
Oct 24, 2003
Review
95 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
16

Its longest line of descent runs back 7 generations to K910422 (1992). 99 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.

  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 deviceK032221 Adept 1064/755 LaserAdept Medical Concepts · 2003
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)K032221Adept 1064/755 LaserAdept Medical Concepts2003—

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
FIG. 1 — Lineage of K032221, 1992–2003Source: 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? (16)

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
*K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002—
*K992757Cynosure Apogee-TKS Dermatological Laser
Summary page 1
…Product Code: GEX Panel: 79 Predicate devices: The Depilase Twin LASE Laser (KO204 12); Cynosure Apogee-TKS Laser (K992757); Candela GentleLASE GL (K994260) and GentleLASE I1 (K98460 1); Altus Family CoolGlide Aesthetic Lasers (KO…
Cynosure, Inc.2000—
*K994260Candela Gentlelase GL Dermatological Laser
Summary page 1
…Panel: 79 Predicate devices: The Depilase Twin LASE Laser (KO204 12); Cynosure Apogee-TKS Laser (K992757); Candela GentleLASE GL (K994260) and GentleLASE I1 (K98460 1); Altus Family CoolGlide Aesthetic Lasers (KO14040, K003202,…
Candela Corp.2000—
*K984601Candela Gentlelase II Dermatological Laser
Summary page 1
…Depilase Twin LASE Laser (KO204 12); Cynosure Apogee-TKS Laser (K992757); Candela GentleLASE GL (K994260) and GentleLASE I1 (K98460 1); Altus Family CoolGlide Aesthetic Lasers (KO14040, K003202, K023954, K022226, K98 1798); and the Lyra Seri…
Candela Corp.1999—
*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
…er (K992757); Candela GentleLASE GL (K994260) and GentleLASE I1 (K98460 1); Altus Family CoolGlide Aesthetic Lasers (KO14040, K003202, K023954, K022226, K98 1798); and the Lyra Series Surgical Laser System (K990903, K00…
Altus Medical2001—
*K023954Altus Medical Coolglide Laser Systems and Accessories
Summary page 1
…57); Candela GentleLASE GL (K994260) and GentleLASE I1 (K98460 1); Altus Family CoolGlide Aesthetic Lasers (KO14040, K003202, K023954, K022226, K98 1798); and the Lyra Series Surgical Laser System (K990903, K003765, KO03 147, KO10284, K01083…
Altus Medical, Inc.2003—
*K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…
Summary page 1
…ela GentleLASE GL (K994260) and GentleLASE I1 (K98460 1); Altus Family CoolGlide Aesthetic Lasers (KO14040, K003202, K023954, K022226, K98 1798); and the Lyra Series Surgical Laser System (K990903, K003765, KO03 147, KO10284, K010834, K02002…
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
…Family CoolGlide Aesthetic Lasers (KO14040, K003202, K023954, K022226, K98 1798); and the Lyra Series Surgical Laser System (K990903, K003765, KO03 147, KO10284, K010834, K020021) and the and Depilase Twin YAG Laser (K020697). Device descr…
Laserscope1999—
*K003765Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)
Summary page 1
…oolGlide Aesthetic Lasers (KO14040, K003202, K023954, K022226, K98 1798); and the Lyra Series Surgical Laser System (K990903, K003765, KO03 147, KO10284, K010834, K020021) and the and Depilase Twin YAG Laser (K020697). Device description: T…
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 & Accessories
Summary page 1
…O14040, K003202, K023954, K022226, K98 1798); and the Lyra Series Surgical Laser System (K990903, K003765, KO03 147, KO10284, K010834, K020021) and the and Depilase Twin YAG Laser (K020697). Device description: The Adept 1064/755 Laser comb…
Laserscope2001—
*K020021Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)
Summary page 1
…003202, K023954, K022226, K98 1798); and the Lyra Series Surgical Laser System (K990903, K003765, KO03 147, KO10284, K010834, K020021) and the and Depilase Twin YAG Laser (K020697). Device description: The Adept 1064/755 Laser combines a lo…
Laserscope2002—
*K020697Depilase Twin Yag Laser System
Summary page 1
…yra Series Surgical Laser System (K990903, K003765, KO03 147, KO10284, K010834, K020021) and the and Depilase Twin YAG Laser (K020697). Device description: The Adept 1064/755 Laser combines a long pulse Nd:YAG laser which emits energies at 10…
Depilase Group, Ltd.2002—

Also cleared against K020412: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 99 ancestors have a recall of any class.
  • 1 other device also cites its predicate K020412.

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 1064/755 Laser is indicated for coagulation and hemostasis of vascular lesions and removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen. The Adept 1064/755 Laser is intended for: 755 nm wavelength The coagulation and hemostasis of vascular lesions and the…

Read the full statement (675 words)

The Adept 1064/755 Laser is indicated for coagulation and hemostasis of vascular lesions and removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

The Adept 1064/755 Laser is intended for:

755 nm wavelength

The coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.

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 1064/755 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 1064/755 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.

For the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.

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).

For the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

For the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.

Endoscopic/Laparoscopic Surgery:

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 (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, thoracotomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, 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.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K032221: Adept 1064/755 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032221

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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