510(k) · Cleared
ClearedRapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medency S.R.L. · GEX Powered Laser Surgical Instrument
Cleared on Oct 24, 2024 after a 240-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 24, 2024
- Review
- 240 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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 –…
Read the full statement (497 words)
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K240543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240543: Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240543
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026