Model: Boston Pico755
DI: 06971782584252
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-10
Current Version: 2026-05-18
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ecf39534-b651-49d2-8ab1-1cc4e320ccf3
Distribution Status:
In Commercial Distribution
DUNS Number:
544317730
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06971782584252
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36150
Name: General/multiple surgical frequency-doubled solid-state laser system
Definition:
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.
FDA Product Codes
GEX
Powered Laser Surgical Instrument
Premarket Submissions
Submission Number:
K252369
Supplement Number:
000