Stellar M22 for Intense Pulsed Light (IPL) and Laser System

Lumenis, Inc.

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

2

Device details

FDA 510(k) registration fields

K number
K193500
Device name
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
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

1

K193500 references 1 predicate/reference device

Cited as predicate

2

2 submissions cite K193500 as a predicate