# K240543: Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

- Pathway: 510(k) (Traditional)
- Applicant: Medency S.R.L.
- Decided: Oct 24, 2024 after 240 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Rapido Medical Laser is generally indicated for use in incision, excision, vaporization, ablation, cutting and hemostasis, or coagulation of soft tissue in General surgery, Gynecology, Neurosurgery, Endovascular coagulation (EVLT/EVLA), Urology, Podiatry and Orthopedics, Dermatology, Plastic surgery and Aesthetics, Otolaryngology (ENT) and Oral surgery. Rapido MED Wavelength: 980nm General surgery – Rectal and anal hemorrohoidectomy – Mastectomy – Dermabrasion – Appendectomy (open and laparscopic) – Bowel resection (open and laparscopic) – Colectomy – Liver resection – Resection of organs – Thyriodectomy – Adhesiolysis – Hepatobiliary tumors – Thoracotomy – Cholecystectomy (open and laparscopic) – Condyloma – Breast biopsy Neurosurgery – Percutaneous Disc Decompression (PLDD) – Discectomy – Hemostasis in conjunction with meningiomas Gynecology – Cervical conization – Myomnectomy – Endometrial ablation – Ovarian cystectomy – Appendectomy Endovascular coagulation (EVLT/EVLA) – Endoluminal or endovenous laser surgery for saphenous veins (EVLA) Urology – Vaporization of urethral tumors – Release of urethral stricture – Removal of bladder neck obstruction – Excision and vaporization of condyloma – Lesions of external genitalia – Vaporization of the prostate to treat benign prostatic hyperplasia (BPH). Wavelength: 1470nm - Vaporization, incision, excision, ablation, cutting and hemostasis - Urology - Plastic Surgery - General Surgery - Gynecology - Endovascular coagulation - Laser assisted lipolysis Wavelength: 1940nm - Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue Rapido ENT Wavelength: 810nm Otolaryngology (ENT) and Oral surgery – Removal of benign lesions from the ear, nose and throat – Excision of carcinoma of the larynx – Incision and excision of carcinoma in situ – Neck dissection – Laryngeal papillomectomy – Removal of vocal cord/fold nodules, polyps and cyst Wavelength: 450nm - Incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue Rapido PODIA Wavelength: 1064nm Podiatry – Excision of periungual and subungual warts – Excision of plantar warts – Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyte trichophyton rubrum and t. Mentagrophyte, and/or yeasts candida albicans, etc.) Wavelength: 810nm Orthopedics – Coagulate Rapido DERMA Wavelength: 980nm Dermatology/Aesthetics – Photocoagulation of vascular & dermatological lesions of the face and extremities – Photocoagulation of telangiectasia, veinulectasia of the legs and face – Treatment of reticular veins and branch varicosities – Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas – Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigments lesions as lentigines. Epidermal nevi, spider nevi. – Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment. – Seborrheic keratosis – Mixoid cyst – Papillary varix – Acne treatment Plastic surgery – Cut, coagulation & vaporization – Resurfacing non-contact – Blepharopasty Wavelength: 635nm - Adjunctive use in providing temporary relief of nociceptive musculoskeletal pain Wavelength: 1470nm - Vaporization, incision, excision, ablation, cutting and hemostasis - Coagulation of soft tissues - Plastic Surgery - Vascular lesions - Dermatology - Laser assisted lipolysis Wavelength: 450nm - Incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue

Source page: https://510kreport.com/device/K240543
Methodology: https://510kreport.com/methodology