510(k) · Cleared
ClearedAdept 1064/532/755 Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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. 104 later devices descend from it.
- 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). 104 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 2 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 1 generation backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- This deviceK032218 Adept 1064/532/755 LaserAdept Medical Concepts · 2003
- Descendant · cites it directly · 96 of its ownK083207 Ultrawave Iii EX 1320Quanta System Spa · 2008 · Recalled
- Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 2 generations on · 40 of its ownK123168 Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · Recalled
- Descendant · 2 generations on · 38 of its ownK130256 MDK Multi-Applications PlatformQuanta System Spa · 2013
- Descendant · 3 generations on · 37 of its ownK152012 EVO platformQuanta System Spa · 2015
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K083207Ultrawave Iii EX 1320Quanta System Spa · 2008 · cites it directly96descendants
- K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants
- K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · 2 generations on40descendants
- K130256MDK Multi-Applications PlatformQuanta System Spa · 2013 · 2 generations on38descendants
- K152012EVO platformQuanta System Spa · 2015 · 3 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −2 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −1 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| 0 (this device) | K032218 | Adept 1064/532/755 Laser | Adept Medical Concepts | 2003 | — |
| +1 | K083207 | Ultrawave Iii EX 1320 | Quanta System Spa | 2008 | 1 |
| +2 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +2 | K123168 | Q-Plus T+ Ipl Laser System | Quanta System Spa | 2012 | 1 |
| +2 | K130256 | MDK Multi-Applications Platform | Quanta System Spa | 2013 | — |
| +3 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 12 | 0 |
| 2002 | 13 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 10 | 0 |
| 2021 | 3 | 0 |
| 2022 | 16 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 12 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020412 | Depilase Twin Lase Laser System | 2002 |
| * | K020697 | Depilase Twin Yag Laser SystemSummary page 1…Product Code: GEX Panel: 79 Predicate devices The Depilase Twin LASE Laser (KO204 12) and Depilase Twin YAG Laser (K020697), Cynosure Apogee-TKS Laser (K992757), Candela GentleLASE GL (K994260) and GentleLASE I1 (K984601), Altus… | 2002 |
| * | K992757 | Cynosure Apogee-TKS Dermatological LaserSummary page 1…Panel: 79 Predicate devices The Depilase Twin LASE Laser (KO204 12) and Depilase Twin YAG Laser (K020697), Cynosure Apogee-TKS Laser (K992757), Candela GentleLASE GL (K994260) and GentleLASE I1 (K984601), Altus Family CoolGli… | 2000 |
| * | K994260 | Candela Gentlelase GL Dermatological LaserSummary page 1…in LASE Laser (KO204 12) and Depilase Twin YAG Laser (K020697), Cynosure Apogee-TKS Laser (K992757), Candela GentleLASE GL (K994260) and GentleLASE I1 (K984601), Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226… | 2000 |
| * | K984601 | Candela Gentlelase II Dermatological LaserSummary page 1…Depilase Twin YAG Laser (K020697), Cynosure Apogee-TKS Laser (K992757), Candela GentleLASE GL (K994260) and GentleLASE I1 (K984601), Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K98… | 1999 |
| * | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 |
| * | K003202 | Family of Altus Medical Coolglide Aesthetic Lasers, Models I & IISummary page 1…(K992757), Candela GentleLASE GL (K994260) and GentleLASE I1 (K984601), Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K981798), and the Lyra Series Surgical Laser System (K990903. K003765,… | 2001 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 1…), Candela GentleLASE GL (K994260) and GentleLASE I1 (K984601), Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K981798), and the Lyra Series Surgical Laser System (K990903. K003765, KO… | 2003 |
| * | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Summary page 1…a GentleLASE GL (K994260) and GentleLASE I1 (K984601), Altus Family CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K981798), and the Lyra Series Surgical Laser System (K990903. K003765, KO03 147, K… | 2002 |
| * | K991798 | Acme 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”. | 2000 |
| * | K990903 | Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Summary page 1…amily CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K981798), and the Lyra Series Surgical Laser System (K990903. K003765, KO03 147, K010284, KO10834, K020021) Device description The Adept 1064/532/755 Laser combines a… | 1999 |
| * | K003765 | Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Summary page 1…CoolGlide Aesthetic Lasers (KO 14040, K003202, K023954, K022226, K981798), and the Lyra Series Surgical Laser System (K990903. K003765, KO03 147, K010284, KO10834, K020021) Device description The Adept 1064/532/755 Laser combines a long pul… | 2001 |
| * | K003147 | Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration) | 2000 |
| * | K010284 | Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Summary page 1…sers (KO 14040, K003202, K023954, K022226, K981798), and the Lyra Series Surgical Laser System (K990903. K003765, KO03 147, K010284, KO10834, K020021) Device description The Adept 1064/532/755 Laser combines a long pulse Nd YAG laser which e… | 2001 |
| * | K010834 | Lyra Series Surgical Laser System & Accessories | 2001 |
| * | K020021 | Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Summary page 1…03202, K023954, K022226, K981798), and the Lyra Series Surgical Laser System (K990903. K003765, KO03 147, K010284, KO10834, K020021) Device description The Adept 1064/532/755 Laser combines a long pulse Nd YAG laser which emits energies at 1… | 2002 |
What descends from it? (104)
See all 1043 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K083207 (Quanta System Spa, 2008) has gone furthest, with 96 descendants of its own.
- 1 other device also cites its predicate K020412.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Adept 1064/532/755 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. 755 nm wavelength For the coagulation and hemostasis of vascular lesions and the removal and permanent reduction of…
Read the full statement (964 words)
The Adept 1064/532/755 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.
755 nm wavelength
For 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 1064/532/755 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 1064/532/755 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 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:
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.
532 nm wavelength
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 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 (incision/excision), 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, Thoracotomy, 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; Lesions of the external genitalia (including condyloma acuminata).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032218: Adept 1064/532/755 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032218
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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