Manufacturer
Lumenis, Inc.Stellar M22 for Intense Pulsed Light (IPL) and Laser System
Country / Region:Israel (IL)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K193500
- Device name
- Stellar M22 for Intense Pulsed Light (IPL) and Laser System
- Company
- Lumenis, Inc.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-12-17
- Decision date
- 2020-01-16
- Submission type
- Special
- Technology type
- IPL(AI inferred)
- Clinical applications
- Hair removalSkin resurfacingPigment treatmentVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The subject Stellar M22 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: - 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, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations - 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 - 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: - 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 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 - The non-ablative treatment of facial wrinkles - ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: - Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue - The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: - Removal of dark tattoos - 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.
Intended Use
The subject Stellar M22 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: 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, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; 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; 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: 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 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; The non-ablative treatment of facial wrinkles. ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: Removal of dark tattoos; 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.
Device Description
The subject Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a multi-application, multi-technology platform with four (4) available treatment handpieces: Stellar Intense Pulsed Light (IPL) handpiece; Multi-Spot Nd:YAG laser handpiece; ResurFX non-ablative laser 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 530-650 & 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 and metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.
Summary parsed at:2026-06-01 05:47:28 UTC
Predicate devices
1M22 and ResurFx Systems
K193500 references 1 predicate/reference device
Cited as predicate
2SmoothCool HR System
Stellar M22
2 submissions cite K193500 as a predicate
