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The ADEPT ULTRALITE 532 LASER is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue. Examples include: Telangiectasia Spider Naevi Angioma Hemangioma Leg veins (small, superficial) Epidermal Naevi Lentigines (solar and senile) Verrucae Vulgares (Warts) Cherry Angioma Port Wine Stain

The Adept UltraLite 532 Laser is a diode laser which emits coherent light at 532 nm. The Ultralight 532 is a diode pumped solid state frequency doubled laser appliance.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it describes a 510(k) summary for the Adept UltraLite 532 Laser, focusing on its substantial equivalence to predicate devices rather than performance data or analytical/clinical study results.

Specifically, the document states: "Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications/characteristics and intended uses of the UltraLite 532 and the claimed predicates, i.e., the BeautyStar 532 and DioLite 532 lasers."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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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.

Ask a specific question about this device

The Adept 1064/532 Laser is indicated for coagulation and hemostasis of vascular lesions (1064 and 532 nm wavelengths) and removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types (1064 nm wavelength). Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

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 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 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.

The Adept Laser is also indicated for the treatment of facial wrinkles such as, but not limited to, periocular and periorbital wrinkles.

The Adept Laser is indicated 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).

The Adept Laser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The Adept Laser is indicated for use on all skin types (Fitzpatrick I - I V) 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:
The Adept Laser is indicated for use in a variety of surgical procedures in several surgical These include, but are not limited to, cholecystectomy, appendectomy, specialties. vagotomy, and pyloromyomotomy where its abilities to incise, coagulate, vaporize, or ablate soft tissue may be applied.

General Surgerv:
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 arrway 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/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
The Adept 1064/532 Laser is intended for the coagulation and hemostasis of vascular lesions (1064 and 532 nm wavelengths).

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, café 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 endartecetomy and/or by-pass grafts, Wedge Resections, Thoractomy, Formation of Pacemaker pockets. Vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (Thoracoscopy).

Urology:
Superficial urinary bladder tumors, invasive bladder All applications including: carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).

The Adept 1064/532 is a long pulse Nd:YAG laser which emits its energy at 1064 nm or 532 nm (frequency doubled wavelength).

The Adept 1064/532 Laser is a surgical laser device. The provided text outlines its intended uses and claims of substantial equivalence to predicate devices, but does not include a study proving device performance against specific acceptance criteria.

The document explicitly states:
"Performance Data: None required. The claim of substantial equivalence is based on comparisons of specification/characteristics and intended uses of the Adept 1064/532 and the claimed predicates."

Therefore, based on the provided text, the following information cannot be extracted:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The basis for the 510(k) clearance was "substantially equivalent" to predicate devices, primarily through a comparison of product specifications and indicated uses, not through new performance studies.

Ask a specific question about this device

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). 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 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 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 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 turnors 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, 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, café 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: Adiunctive 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 a 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 endartecetomy and/or by-pass grafts, Wedge Resections, Thoractomy, 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).

The Adept 1064/532/755 Laser combines a long pulse Nd: Y AG laser which emits energies at 1064 nm with a KTP crystal which converts the 1064 nm laser to 532 nm and an alexandrite laser which emits energy at 755 nm.

The provided text for Adept 1064/532/755 Laser (K032218) states: "Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications/characteristics and intended uses of the claimed predicate."

Therefore, based on the provided input, there is no performance data, acceptance criteria, or study described for the Adept 1064/532/755 Laser to prove it meets any specific acceptance criteria. The device's submission relies on showing substantial equivalence to predicate devices, not on direct performance testing proving efficacy against defined metrics.

Consequently, none of the requested information (table of acceptance criteria, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, or training ground truth establishment) can be extracted from the provided text.

Ask a specific question about this device