Model: Rapido Podia
Catalog: MD.RAPIDO.29.04.POD
DI: 08059340291083
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Wavelength: 810nm/1064nm, Max power: 10W
The model Rapido Podia of the family of medical devices "Rapido Medical Laser" is a laser medical device with surgical and therapeutic effects intended to be used in podiatry, including the treatment of onychomycosis and diabetic foot wounds. It’s also intended for traumatology and pain therapy. It’s a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
989f248e-616e-4e4d-a464-e35a8125617c
Distribution Status:
In Commercial Distribution
DUNS Number:
436042800
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08059340291083
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60341
Name: General/multiple surgical diode laser system
Definition:
An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.
FDA Product Codes
GEX
Powered Laser Surgical Instrument
Premarket Submissions
Submission Number:
K240543
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling Low - @attributes - Value:
70
Item #1 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling High - @attributes - Value:
160
Item #1 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
30
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
70
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
10
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
30
Item #3 - Storage Handling Type:
Handling Environment Temperature
Item #4 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling Low - @attributes - Value:
50
Item #4 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling High - @attributes - Value:
160
Item #4 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #5 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling Low - @attributes - Value:
30
Item #5 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling High - @attributes - Value:
70
Item #5 - Storage Handling Type:
Storage Environment Humidity
Item #6 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling Low - @attributes - Value:
5
Item #6 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling High - @attributes - Value:
50
Item #6 - Storage Handling Type:
Storage Environment Temperature