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ET LightSheer 1060 and High Speed LightSheer 1060 are intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbae (PFB ).

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 regime.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, café-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are also intended for treatment of wrinkles.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The ET LightSheer 1060 and High Speed LightSheer 1060 are two treatment handpieces, intended to be used with Lumenis LightSheer Duet Laser System.

One handpiece is the ET LightSheer 1060 handpiece, which delivers laser energy through a 9 x 9 mm tip up to 90 J maximum. The settings for this handpiece are selectable pulse duration from 5 - 400 ms, selectable fluence from 10 - 100 J/cm2 and a pulse repetition rate up to 3 Hz maximum.

The second handpiece is the High Speed LightSheer 1060 handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 93 J maximum. The settings for this handpiece are pulse duration from 10 - 100ms, selectable fluence from 4.5 - 12 J/cm2 and multiple pulsing up to 3 pulses.

The ET LightSheer 1060 handpiece tip is water-cooled to provide active skin cooling. The High Speed LightSheer 1060 handpiece tip uses vacuum and lower laser energy densities which reduce skin heating.

This 510(k) summary for the Lumenis ET LightSheer 1060 and High Speed LightSheer 1060 describes the device's technical characteristics and claims substantial equivalence to predicate devices, but does not provide details of a specific clinical study with acceptance criteria and results in the way typically expected for a device proving performance against set criteria.

Instead, the submission relies on demonstrating substantial equivalence through:

• Same intended use, principles of operation, and mechanism of action as previously cleared predicate devices.
• Equivalent performance characteristics to predicate devices.
• Identical materials and manufacturing methods to a previously cleared Lumenis device (K053628).
• Conformity to established electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, and IEC 60825-1).

Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text, nor can I answer many of the specific questions about clinical study design. There is no mention of sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for clinical performance. Similarly, no multi-reader multi-case (MRMC) or standalone algorithm performance studies are described.

The "Testing" section focuses on bench testing and compliance with safety standards, rather than clinical performance studies against specific acceptance criteria. The "Conclusion" explicitly states that the evaluation "does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device," indicating that the submission primarily leveraged the predicate device framework for clearance.

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The Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

Dermatology:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also 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 black and/or blue/black tattoos) and plaques. Additionally, the lasers are 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.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

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). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Surgical Applications:

Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Profile Laser System is an Nd:YAG laser producing emission at a wavelength of 1064nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

The provided text describes a 510(k) submission for the Sciton Profile 1064 Laser System, demonstrating its substantial equivalence to previously marketed predicate devices. This type of submission generally relies on demonstrating equivalence rather than conducting new clinical studies with defined acceptance criteria and performance metrics.

Therefore, this document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it is a regulatory submission focused on substantial equivalence rather than a study report detailing specific performance criteria, test sets, or training sets for an AI/ML device.

Here's why the information is not present based on the provided text:

• Acceptance Criteria and Reported Device Performance (1): The submission focuses on substantial equivalence to predicate devices, meaning its performance is considered acceptable if it is similar to those already on the market. There are no explicit acceptance criteria or a quantitative performance table mentioned.
• Sample Size, Data Provenance (2): No new clinical study data with test sets, sample sizes, or data provenance is presented. The argument is based on the similarity of the device's technological characteristics and intended use to existing devices.
• Experts, Qualifications, Adjudication (3, 4): These details are relevant for studies establishing ground truth, which is not the primary mechanism of this 510(k) submission.
• MRMC Study (5): The submission does not mention an MRMC study or any assessment of human reader improvement with AI assistance, as the device is a laser system, not an AI-assisted diagnostic tool.
• Standalone Performance (6): Similar to the above, this concept applies to AI/ML devices, not a laser system.
• Type of Ground Truth (7): Ground truth is not established in this context as new clinical validation is not the basis of the submission.
• Training Set Sample Size/Ground Truth (8, 9): These concepts are applicable to AI/ML model development. This submission is for a physical medical device (laser system), not an AI algorithm.

In summary, the provided 510(k) summary focuses on demonstrating that the "Profile 1064 Laser System" is substantially equivalent to other legally marketed Nd:YAG laser systems based on shared indications for use and technological characteristics. It is not a report of a study designed to establish new performance criteria or to validate an AI/ML algorithm against a ground truth dataset.

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The family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also 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 black and/or blue/black tattoos) and plaques.

Additionally, the lasers are 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.

The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and periorbital wrinkles.

The CoolGlide lasers are also indicated 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).

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

The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The intended use of the integral cooling system in the Altus handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Optional Pulsed Light Hand Piece:
For the treatment of benign pigmented lesions.

Surgical Applications ::
The lasers are indicated for the incision/excision and cutting, ablation. coagulation/hemostatis of soft tissue in the performance of surgical applications in endosopy/laproscopy, gastroenterology, g general surgery, surgery, g head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Indications for use (532nm):
For coagulation 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).

The Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece are comprised of the following main components:

• · a laser system console (including software and control electronics);
• · a control and display panel;
• · a permanently attached fiberoptic-coupled handpiece;
• · a skin cooling device integrated into the handpiece;
• a footswitch
• · a remote interlock connector (disables laser when treatment room door is opened)
• · optional pulsed light hand piece that can be removed by either the user or a qualified service person.

The provided text is a 510(k) summary for the Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece. This document is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study reporting specific performance metrics against acceptance criteria for a new, novel AI/software-as-a-medical-device (SaMD) product.

Therefore, the document does not contain the kind of detailed information requested about acceptance criteria, specific device performance, study methodology, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies for an AI/SaMD.

The document primarily focuses on:

• Predicate Devices: Identifying existing legally marketed devices to which the new device is substantially equivalent.
• Indications for Use: Listing the medical conditions and applications for which the device is intended.
• Technological Equivalence: Stating that the new device shares similar design features and functional features with predicate devices.
• Safety and Effectiveness: Concluding that no new questions of safety or effectiveness are raised because it's substantially equivalent to existing devices.

Based on the provided text, I cannot fill out the requested table or provide the specific details of a study proving the device meets acceptance criteria. The document does not describe a study in the sense of demonstrating a novel device's performance against predefined metrics, but rather argues for substantial equivalence to devices already on the market.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria and Reported Device Performance: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics are provided. The "performance" is implicitly tied to being "substantially equivalent" to predicate devices, meaning it performs similarly to already cleared devices for the stated indications.
2. Sample Size for Test Set and Data Provenance: This information is not relevant to a substantial equivalence argument based on predicate devices. There is no independent "test set" described for performance validation.
3. Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no independent ground truth establishment for a novel performance claim.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not mentioned, as this is typically for evaluating human performance with and without AI assistance, which is not the context here.
6. Standalone Performance: While the device functions as standalone hardware, there isn't a "standalone algorithm performance" study as would be seen for AI/SaMD.
7. Type of Ground Truth: No specific ground truth is described as being used for performance validation of this device.
8. Sample Size for Training Set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How Ground Truth for Training Set was Established: Not applicable.

In summary, this document is a regulatory submission for a medical device based on substantial equivalence, not a scientific publication detailing performance studies for a novel or AI-powered device.

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