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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/otorhinolarvngology (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). café 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 tem, 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, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excission, 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.

The Adept 1064/755 Laser combines a long pulse Nd: YAG laser which emits energies at 1064 nm and 532 nm and an alexandrite laser which emits energy at 755 nm.

This submission for the Adept 1064/755 Laser does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary for a medical device that seeks substantial equivalence to previously cleared predicate devices. The basis for substantial equivalence is explicitly stated as:

• "Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications/characteristics and intended uses of the claimed predicate." (Page 3)

Therefore, the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not provided in this document. The FDA has cleared this device based on its similarity to existing, legally marketed devices, rather than requiring new clinical performance data.

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