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The Lumenis Stellar M22 system has connection capability with the following available treatment modules, for multi-application treatment options. All modules are designed for aesthetic and dermatological skin procedure application, as follows:

• IPL with a spectrum of 400-1200nm (with different filters) is indicated for:

  • Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
  • Cutaneous lesions, including warts, scars and striae.
  • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
  • Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles.
  • Mild to moderate inflammatory Acne (Acne Vulgaris).

• Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm is indicated for:

  • The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
  • The non-ablative treatment of facial wrinkles.
  • The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles.

• The 1565nm ResurFX module, with a wavelength of 1565 nm, is indicated for:

  • Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

• Q-Switched Nd:YAG Laser, with a wavelength of 1064 nm, is indicated for:

  • Treatment of pigmented lesions.
  • Removal of dark tattoos.

(*) Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.

The Lumenis Stellar M22 System is multi-application, multi-technology system intended for use in aesthetic dermatologic procedures.

The Stellar M22 System operates with four (4) treatment handpieces options (for connection capability), within serial operational mode:

• Intense Pulsed Light (IPL) handpiece;
• Multi-Spot Nd:YAG Laser handpiece;
• ResurFX Laser module and handpiece;
• Q-Switched Nd:YAG laser handpiece.

The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems:

• The Stellar IPL handpiece has nine (9) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530650& 900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter.
• The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes of: 2mm x 4mm, 6 mm, and 9 mm.
• The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips
• The Q-Switched Nd:YAG handpiece has both disposable and gold-plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm, while the metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

This FDA 510(k) clearance letter for the Stellar M22 device does not contain any information about acceptance criteria or a study proving the device meets said criteria for an AI/algorithm-driven component.

The document explicitly states:

• "No new clinical validation was required to support the Stellar M22 as the clinical validation of the Lumenis predicate device also applies to the subject device." This indicates that no new clinical study was performed for this specific submission to demonstrate performance.
• The modifications described are "mainly due to the addition of new Hardware to serve marketing, business and serviced purposes," and "to maintain Lumenis' high-level service capabilities to the professional end-users and their patients, through establishment of a secure transmission of technical information to the cloud for further analysis and rapid problem-solving." This strongly suggests the changes are related to connectivity and serviceability, not a new AI/algorithm feature requiring performance validation.

Therefore, I cannot provide the requested information from the provided text. The document describes a device modification for an existing system (Stellar M22) and asserts substantial equivalence to its predicate based on the fact that the changes are primarily hardware upgrades for service and marketing, and the clinical validation of the predicate device is considered applicable.

There is no mention of any AI component, performance criteria for such a component, or a study validating its performance in this submission.

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The FoLix System, with wavelength of 1565 mm. is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.

The FoLix™ is a laser system intended to be used for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The FoLix™ laser system with a wavelength of 1565 nm and consists of the following:

• The laser console includes a power supply unit, a Laser module (+ aiming beam), a control ● unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
• The handpiece includes a scanner module built of two mirrors that are controlled by two ● motors directing the Laser beam to desired target tissue.
• The handpiece uses a tip to align the Laser beam focus with the target tissue, enabling a . treatment shape size and a thermo-electric cooler (TEC).
  The FoLix™ is intended for professional use only.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the FoLix System, which is a laser system intended for improving the appearance of scalp hair.

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (F65 Laser System, K222790). This means the manufacturer is asserting that the new device is as safe and effective as the predicate device, not necessarily that it meets specific, independently established performance criteria through a new clinical study.

Here's what the document does state regarding validation:

• Summary of Bench Verification: This includes risk analysis (ISO 14971), electrical, laser, and electromagnetic compatibility safety testing (IEC 60601-1 and IEC 60601-1-2), software verification and validation (IEC 62304 and FDA Guidance "Principles of Software Validation"), system testing, and usability assessment (FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices", IEC 62366-1 and IEC 60601-1-6). These are standard engineering and safety tests, not clinical performance acceptance criteria.
• Summary of Clinical Validation: It explicitly states, "No new clinical validation was required to support the FoLix as the clinical validation of the Lumenis predicate device also applies to the subject device." This indicates that any clinical performance claims are based on the predicate device's data, not a new study for the FoLix system with specific acceptance criteria.

Therefore, I cannot provide the requested table or details about a study proving the device meets acceptance criteria because:

1. No Acceptance Criteria are Quantitatively Defined: The document does not list specific, measurable acceptance criteria for device performance (e.g., a certain percentage improvement in hair appearance, specific accuracy/sensitivity/specificity metrics).
2. No New Performance Study Presented: The document explicitly states that no new clinical validation was required. It relies on the clinical validation of its predicate device, of which no details are provided in this text.

To answer your request, information regarding the predicate device's clinical validation, including its acceptance criteria and study details, would be necessary. This document focuses on demonstrating that the FoLix system is substantially equivalent to that predicate, given its modifications (removal of handpieces, minor hardware/software changes).

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The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring:

ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including; dermatology and plastic surgery (aesthetic), podiatry, gyneoology, general and thoracic surgery, dental and oral surgery and genitourinary surgery as follows:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

• · Laser skin resurfacing
• · Laser derm-abrasion
• · Laser burn debridement
• -Laser skin resurfacing (ablation and/or vaporization) for treatment of:
• · Wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
• -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
• · Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheica.
• · Vermillionectomy of the lip
• Cutaneous horns
• · Solar/actinic elastosis
• · Cheilitis, including actinic cheilitis
• · Lentigines, including lentigo maligna or Hutchinson's malignant freckle
• · Uneven pigmentation/dyschromia
• Acne scars
• · Surgical scars
• · Keloids including acne keloidalis nuchae
• · Hemangiomas (including Buccal, port wine and pyogenic granuloma pyogenicum/granuloma telangiectaticum)
• Tattoos
• · Telangiectasia
• · Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
• · Superficial pigmented lesions
• Adenosebaceous hypertrophy or sebaceous hyperplasia
• · Rhinophyma reduction
• · Cutaneous papilloma (skin tags)
• Milia
• Debridement of eczematous or infected skin
• · Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
• · Nevi, including spider, epidermal and protruding
• · Neurofibromas
• · Laser de-epithelialization
• · Tricoepitheliomas
• · Xanthelasma palpebrarum
• · Syringoma
  -Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy.
• Vaporization or coagulation of:
• · Benign and malignant vascular/avascular skin lesions
• · Moh's Surgery
• Lipectomy
• · Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts
  -Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
  -Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation

Podiatry
Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:

• Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
• Porokeratoma ablation
• · Ingrown nail treatment
• Neuromas/fibromas, including Morton's neuroma
• Debridement of ulcers
• Other soft tissue lesions
  Laser ablation, vaporization, and/or excision for complete and partial matrixectomy

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:

• · vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
• · Condyloma acuminata, including genital, vulvar, perineal, and Bowen's disease (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions
• · Leukoplakia (vulvar dystrophies)
• · Incision and drainage (I&D) of Bartholin's and nubuthian cysts
• · Herpes vaporization
• Urethral caruncle vaporization
• Benign and malignant tumors
• · Hemangiomas

General Surgery

• Debridement of traumatic wounds
• Debridement of decubitus and diabetic ulcers
• · Microsurgery
• · Artificial joint revision
• PMMA removal

General and Thoracic Surgery
Incision, excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

• · Debridement of decubitus ulcers, stasis, diabetic, and other ulcers
• · Mastectomy
• Debridement of burns
• Rectal and anal hemorrhoidectomy
• · Breast biopsy
• · Reduction mammoplasty
• · Cytoreduction for metastatic disease
• · Laparotomy applications
• · Mediastinal and thoracic lesions and abnormalities
• Skin tag vaporization
• Atheroma
• · Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
• · Pilonidal cyst removal and repair
• Abscesses
• · Other soft tissue applications

Dental and Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

• · Gingivectomy/removal of hyperplasias
• · Gingivoplasty
• · Incisional and excisional biopsy
• · Treatment of ulcerous lesions, including aphthous ulcers
• · Incision of infection when used with antibiotic therapy
• · Frenectomy (frenum release)
• · Excision and ablation of benign and malignant lesions
• · Homeostasis
• · Operculectomy
• · Crown lengthening
• · Removal of soft tissue, cysts and tumors
• Oral cavity tumors and hemangiomas
• Abscesses
• · Extraction site hemostasis
• Salivary gland pathologies
• · Preprosthetic gum preparation
• Leukoplakia
• · Partial glossectomy
• Periodontal gum resection

Genitourinary
Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:

• · Benign and malignant lesions of external genitalia
• Condyloma
• Phimosis
• · Erythroplasia

The Lumenis Be modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, gynecology, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, reported device performance, sample sizes, ground truth establishment, or any studies conducted to prove the device meets acceptance criteria. The document primarily focuses on the regulatory clearance process and the device's indications for use. Therefore, I cannot fulfill your request based on the given input.

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The subject F65 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:

• o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)
• o Cutaneous lesions, including warts, scars and striae
• o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
• o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• o Mild to moderate inflammatory Acne (Acne vulgaris)

The Nd: YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: YAG) is indicated for:

• o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
• o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• o The non-ablative treatment of facial wrinkles

The F65 module and handpiece, with wavelength of 1565 nm, are indicated for:

• o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
• o Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.

The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
o Removal of dark tattoos
o Treatment of pigmented lesions

*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

The Lumenis Be F65 Laser System is intended to be used for the new indication for Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The description here is limited to the system module required to support the new indication which is the subject of this 510(k):

• The laser console includes a power supply unit, a Laser module (+ aiming beam), a control unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
• . The handpiece includes a scanner module – built of two mirrors that are controlled by two motors directing the Laser beam to desired target tissue.
• . The handpiece uses a tip (user may choose from two types) to align the Laser beam focus with the target tissue, enabling a treatment shape size and a tip thermo-electric cooler (TEC).

The F65 is intended for professional use only.

The provided FDA 510(k) summary only describes the clinical studies for the F65 module and handpiece with 1565 nm wavelength, specifically for the new indication of "Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss." It does not provide detailed acceptance criteria and performance data for all the device's indications, nor does it present the information in a clear table format for acceptance criteria vs. device performance.

Based on the information provided for the 1565nm module and its new indication:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new indication ("Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss") are implicitly derived from the study results presented in the document. The document states a primary efficacy endpoint of "demonstrating improvement in more than 70% of subjects" for the retrospective study.

2. Sample Sizes and Data Provenance

• Preclinical Study (Animal Testing): Sample size for the preclinical study is not specified, only that it "was conducted to evaluate the Lumenis F65 subject module for hair follicle regeneration capabilities using both Low Level Laser Therapy (LLLT) and untreated controls."
• Clinical Studies:
  • Prospective, Single Arm Study:
    • Sample Size: 32 subjects enrolled, 25 completed.
    • Diagnosis Breakdown: 18 with Androgenic Alopecia, 7 with other diagnoses (evaluated separately).
    • Hair Count Data: 5 male subjects with androgenic alopecia, 18 female subjects with androgenic alopecia.
    • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. No country of origin is mentioned.
  • Retrospective, Single Arm Study:
    • Sample Size: 98 subjects evaluated for performance.
    • Diagnosis Breakdown: 44 with confirmed Androgenic Alopecia, 54 with no documented diagnosis (presumably hair loss but not specifically diagnosed as androgenic alopecia).
    • Data Provenance: Retrospective. No country of origin is mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Retrospective Study: "a group of 3 blinded reviewers" were used for the assessment of improvement in scalp hair appearance.
• Qualifications of Experts: The specific qualifications (e.g., dermatologist, years of experience) of these 3 blinded reviewers are not specified in the provided document. They are only referred to as "reviewers."

4. Adjudication Method for the Test Set

• For the retrospective study, where 3 blinded reviewers assessed improvement, the adjudication method is not explicitly stated. It's mentioned they "yielded a correct identification" in a certain percentage of cases. This implies either:
  • All 3 reviewers had to agree (unlikely for such high percentages given typical inter-reader variability without prior agreement).
  • A majority vote (2 out of 3) was used.
  • One expert's assessment was deemed primary, or they collectively discussed and reached a consensus.
    The document does not detail the process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human readers with AI assistance vs. without AI assistance.
• The studies described are for the device's direct effect on hair growth, not for evaluating human reader performance with or without an AI. The "blinded reviewers" in the retrospective study were assessing the clinical outcome (improvement in scalp hair appearance), not the performance of an AI algorithm.

6. Standalone (Algorithm Only) Performance

• This document describes a medical device (laser system) that directly treats patients, not an AI algorithm. Therefore, there was no standalone (algorithm only) performance study as it's not an AI device. The "performance" refers to the clinical outcome achieved by the laser system.

7. Type of Ground Truth Used

• For the clinical studies, particularly the retrospective study, the "ground truth" for showing improvement in scalp hair appearance was established by expert consensus/review (3 blinded reviewers).
• For the prospective study, quantifiable metrics like mean increase in hair count per cm² from baseline were reported, which can be considered objective outcomes data.

8. Sample Size for the Training Set

• This document describes physical medical device studies (laser system) for a 510(k) submission, not an AI model requiring a training set. Therefore, there is no concept of a "training set" in the context of this submission. The "training" here refers to the device's design and manufacturing through engineering principles and prior knowledge, not machine learning.

9. How the Ground Truth for the Training Set Was Established

• As there is no AI model or "training set" in the context of this device submission, this question is not applicable.

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The UltraPulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: dermatology and plastic surgery (aesthetic), podiatry , gynecology, general and oral surgery, dental and oral surgery and genitourinary surgery as follows:

The UltraPulse SurgiTouch and UltraPulse Encore CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:

The Lumenis Be Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (subject devices) consist of the following devices:

Laser Systems

• o UltraPulse Alpha (also written as UltraPulse α)
• UltraPulse Encore o
• UltraPulse SurgiTouch o

Delivery Devices and Accessories

• o DeepFX Microscanner and disposable tips
• UltraScan CPG Microscanner o
• o TrueSpot 2.0 mm Collimated Handpiece
• o 0.2 mm and 1.0 mm Focused Incisional Handpieces (also called Standard Handpieces)

Each UltraPulse laser system is an advanced computer-controlled device with RF - modulated CO2 laser tube technology that emits laser beams at a wavelength of 10,600 or 11,100 nm. Each has an additional diode laser in the red visible spectrum emitting along the same optical path as the CO2 to serve as an aiming beam.

Attached to each laser system are the delivery devices and accessories that direct the laser beams to the intended treatment site in the format as selected by the user.

This document is a 510(k) premarket notification decision letter from the FDA regarding a CO2 Laser System for surgical and aesthetic applications. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document states:

• "For the labeling changes described in the 510(k), no testing was required." (Page 12)
• The entire submission is focused on "labeling changes" and a new manufacturer name, not performance evaluation of a new or modified device functionality that would require clinical or technical studies demonstrating performance metrics.
• The device being cleared is a traditional medical laser system, not an AI or algorithm-based device. Therefore, the concepts of "ground truth," "expert consensus," "training set," "test set," "MRMC study," and "human readers improve with AI assistance" are not applicable to this document.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert information, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) from the provided text. The document pertains to a regulatory clearance based on substantial equivalence for a non-AI device with labeling changes, not a performance study for an AI-enabled device.

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