# K032218: Adept 1064/532/755 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Adept Medical Concepts
- Decided: Oct 24, 2003 after 95 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910422 (1992). 99 ancestors in all.
104 later devices descend from it; 3 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020412: Depilase Twin Lase Laser System, Depilase Group, Ltd. (2002)
- K020697: Depilase Twin Yag Laser System, Depilase Group, Ltd. (2002) Summary page 1.
- K992757: Cynosure Apogee-TKS Dermatological Laser, Cynosure, Inc. (2000) Summary page 1.
- K994260: Candela Gentlelase GL Dermatological Laser, Candela Corp. (2000) Summary page 1.
- K984601: Candela Gentlelase II Dermatological Laser, Candela Corp. (1999) Summary page 1.
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models, Altus Medical, Inc. (2002)
- K003202: Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II, Altus Medical (2001) Summary page 1.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 1.
- K991798: Acme Medical Aesthetic ND:Yag Laser, Altus Medical (2000). 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”.
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1.
- K003765: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration), Laserscope (2001) Summary page 1.
- K003147: Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration), Laserscope (2000)
- K010284: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration), Laserscope (2001) Summary page 1.
- K010834: Lyra Series Surgical Laser System & Accessories, Laserscope (2001)
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 1.

## Most influential descendants
- K083207: Ultrawave Iii EX 1320 (2008), 96 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K123168: Q-Plus T+ Ipl Laser System (2012), 40 descendants of its own
- K130256: MDK Multi-Applications Platform (2013), 38 descendants of its own
- K152012: EVO platform (2015), 37 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K032218
Methodology: https://510kreport.com/methodology