# K242946: Hestia (L200-a)

- Pathway: 510(k) (Traditional)
- Applicant: Senbitec Co., Ltd.
- Decided: Oct 3, 2025 after 373 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K936109 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 6.

## Indications for use
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;

Source page: https://510kreport.com/device/K242946
Methodology: https://510kreport.com/methodology