Manufacturer
Boston Aesthetics, Inc.Boston Pico755
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252369
- Device name
- Boston Pico755
- Company
- Boston Aesthetics, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-07-30
- Decision date
- 2026-01-21
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentAcne treatmentSkin resurfacing
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The Boston Pico755 is indicated for the removal of tattoos and benign pigmented lesions, including but not limited to Ota nevus, Hori spots (Hori nevus), and melasma. The Boston Pico755 with the 2 mm and 6 mm handpieces and the handpieces with Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
Intended Use
The Boston Pico755 is indicated for the removal of tattoos and benign pigmented lesions, including but not limited to Ota nevus, Hori spots (Hori nevus), and melasma. The Boston Pico755 with the 2 mm and 6 mm handpieces and the handpieces with Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
Device Description
The Boston Pico755 is a medical solid-state laser equipment which is indicated for the removal of tattoos and benign pigmented lesions, including but not limited to: Ota nevus, Hori spots (Hori nevus) and melasma. It has handpieces for the treatment of acne scars and wrinkles in skin types I-IV. The device is intended to be used in professional healthcare facilities by trained physicians only. The subject device Boston Pico755 consists of main unit (including power module, laser module, control system and cooling system), a light guide articulated arm, a footswitch, a handpiece and protective glasses. It is connected to supply mains directly through undetachable power cord and plug. There are 8 types of replaceable handpieces - Zoom S, Zoom X, M, M6, M8, M10, 755x, 755s, and operators can choose the appropriate handpiece according to treatment needs. When the system automatically detects the model of the installed handpiece, it will display the corresponding treatment interface specific to that handpiece. Users can view or adjust relevant parameters such as wavelength, fluence, energy, spot size, and repetition rate directly from the interface. After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Footswitch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. The cooling system controls the heating caused by the laser output.
Summary parsed at:2026-06-01 05:18:35 UTC
Predicate devices
2PicoSure Workstation
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Not ingested
K252369 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252369 as a predicate
