(30 days)
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:
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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).
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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.
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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.
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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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.