510(k) · Cleared
ClearedAdept 1064/755 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.
- 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.
- 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 deviceK032221 Adept 1064/755 LaserAdept Medical Concepts · 2003
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) | K032221 | Adept 1064/755 Laser | Adept Medical Concepts | 2003 | — |
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 |
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 |
| * | K992757 | Cynosure Apogee-TKS Dermatological LaserSummary 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… | 2000 |
| * | K994260 | Candela Gentlelase GL Dermatological LaserSummary 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,… | 2000 |
| * | K984601 | Candela Gentlelase II Dermatological LaserSummary 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… | 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…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… | 2001 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary 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… | 2003 |
| * | K022226 | Altus 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… | 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…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… | 1999 |
| * | K003765 | Lyra 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… | 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) | 2001 |
| * | K010834 | Lyra Series Surgical Laser System & AccessoriesSummary 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… | 2001 |
| * | K020021 | Lyra 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… | 2002 |
| * | K020697 | Depilase Twin Yag Laser SystemSummary 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… | 2002 |
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 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 1064/755 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.
https://510kreport.com/device/K032221 · printed Nov 6, 2026
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