HESTIA (L200-A)

The HESTIA is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery. The HESTIA is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery as follows:

[Dermatology & Plastic Surgery]
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of:
- hemangiomas (including Buccal and port wine);
- removal of small skin tumors;
- milia;
- basal and squamous cell carcinoma;
- tricoepitheliomas;
- syringoma
Laser incision &/or excision of soft tissue for the performance of blepharoplasty.
Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation.

[Podiatry]
Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal, &/or treatment of:
- verrucae vulgares/plantar (warts);
Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy;

[Otolaryngology (ENT)]
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of:
- polypectomy of nose and nasal passages;

[Gynecology]
Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of:
- condyloma acuminata, including cervical, genital, vulvar and perineal;
- hemangiomas

[Genitourinary]
Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:
- condyloma;
- phimosis;

The HESTIA is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery. The HESTIA is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery as follows: [Dermatology & Plastic Surgery] Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of: hemangiomas (including Buccal and port wine); removal of small skin tumors; milia; basal and squamous cell carcinoma; tricoepitheliomas; syringoma. Laser incision &/or excision of soft tissue for the performance of blepharoplasty. Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation. [Podiatry] Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal, &/or treatment of: verrucae vulgares/plantar (warts); Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy; [Otolaryngology (ENT)] Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: polypectomy of nose and nasal passages; [Gynecology] Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of: condyloma acuminata, including cervical, genital, vulvar and perineal; hemangiomas. [Genitourinary] Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include: condyloma; phimosis.

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[Hestia (K242946) vs. Lumenis Ultrapulse Encore and Carbon Dioxide Surgical Laser and Delivery Device
Accessories (K022060)]
The subject device [Hestia] is substantially equivalent to