Indications for Use
The U.S. Food and Drug Administraion (FDA) cleared the following indications of use:
308
510k Approval: K073066
The Quantel 308 Excimer System is intended to be used for the treatment of psoriasis and vitiligo.
ARAMIS II Dermatological Laser
510k Approval: K023734
The Aramis II Dermatological Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis II laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), and for the treatment of periorbital and perioral wrinkles.
510k Approval: K032260
The Aramis II is intended for the treatment of back acne.
ARION
510k Approval: K042472
The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I – IV.
BURANE
510k Approval: K052806
The BURANE is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE is indicated for use in skin resurfacing. The BURANE is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology/Plastic Surgery
Indications include, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterology
General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation.
Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
ENT
Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.
Oral/Maxillofacial
Indications include benign oral tumors, oral and glossal lesions and gingivectomy.
Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
BURANE XL
510k Approval: K050317
The BURANE XL is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE XL is indicated for use in skin resurfacing. The BURANE XL is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology/Plastic Surgery
Indications include epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterology
General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation
Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
ENT
Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.
Oral/Maxillofacial
Indications include benign oral tumors, oral and glossal lesions and gingivectomy.
Ophtalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
EXELO2
FDA approval pending.
IDAS
510k Approval: K053604
The IDAS laser system is intended for use for
Aesthetics
vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. café-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
LEDA and Applicators
Not yet FDA approved.
MYDON C
510k Approval: K040384
The MYDON C laser system is indicated:
1. 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.
2. The MYDON C laser system is also indicated for the treatment of wrinkles.
3. The MYDON C is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculits barbae (PFB).
4. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
5. The intended use of the integral cooling system in the MYDON C laser 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.
SINON
510k Approval: K040433
The SINON is indicated
1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
TALOS
Not FDA approved.
VIRIDIS DERMA
510k Approval: K020071
Indications: The Viridis Derma laser is intended for photocoagulation of pigmented lesions in dermatology.
These include the following applications:
Benign Vascular Lesions, Port Wine Stains, Erythrosis, Cuperosis, Keratoses, Dermatosis Papulosis Nigra (DPN), Leg Telangiectasia - only as a complement to sclerotherapy and for small superficial red vessels,Facial Telangiectasias, Café au-lait, Benign Pigmented Lesions, Senile Lentigo, Hemangiomas (spider and cherry/strawberry).
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