Stellar M22

Lumenis Be, Ltd.

Country / region:Israel (IL)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K250809
Device name
Stellar M22
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-03-17
Decision date
2025-04-16
Submission type
Special
Technology type
Nd:YAG(AI inferred)
Clinical applications
Hair removalPigment treatmentVascular treatmentSkin resurfacing
Primary application
Hair removal
Classification source
AI classified

Indications for Use

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:
  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, hemangiomas, 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 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.
  o Mild to moderate inflammatory Acne (Acne Vulgaris).
● Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm 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 non-ablative treatment of facial wrinkles.
  o 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:
  o 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:
  o Treatment of pigmented lesions.
  o 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.

Intended Use

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: 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, hemangiomas, 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 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. o Mild to moderate inflammatory Acne (Acne Vulgaris). ● Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm 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 non-ablative treatment of facial wrinkles. o 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: o 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: o Treatment of pigmented lesions. o Removal of dark tattoos.

Device Description

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.

Summary parsed at:2026-06-01 05:22:39 UTC

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