Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

Medency S.R.L.

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K240543
Device name
Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-02-27
Decision date
2024-10-24
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacingVascular treatmentAcne treatment
Primary application
Surgical cutting
Classification source
AI classified

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.

General surgery
– Rectal and anal hemorrohoidectomy
– Mastectomy
– Dermabrasion
– Appendectomy (open and laparoscopic)
– Bowel resection (open and laparoscopic)
– Colectomy
– Liver resection
– Resection of organs
– Thyroidectomy
– Adhesiolysis
– Hepatobiliary tumors
– Thoracotomy
– Cholecystectomy (open and laparoscopic)
– Condyloma
– Breast biopsy

Neurosurgery
– Percutaneous Disc Decompression (PLDD)
– Discectomy
– Hemostasis in conjunction with meningiomas

Gynecology
– Cervical conization
– Myomectomy
– 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).

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

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.)

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
– Blepharoplasty

Adjunctive use in providing temporary relief of nociceptive musculoskeletal pain

Intended 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.

Device Description

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is a laser device with multiple wavelengths (980nm, 1470nm, 1940nm, 810nm, 450nm, 1064nm) designed for various surgical applications including incision, excision, vaporization, ablation, cutting, and hemostasis of soft tissue across multiple medical fields.

Summary parsed at:2026-06-01 05:27:47 UTC

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