DeviceClearance

Boston 2910 (Boston 2910)— 510(k) K253245

Substantially Equivalent

Boston Aesthetics, Inc.

FDA 510(k) clearance K253245 for Boston 2910 (Boston 2910), Substantially Equivalent on 2026-05-21. Applicant: Boston Aesthetics, Inc.. Device class: 2.

Summary

Boston Aesthetics' Boston 2910 is filed under GEX, powered laser surgical instruments. The record doesn't describe it beyond its name and that code name.

Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Boston Aesthetics filed from Wilmington, Delaware. Review took 234 calendar days (September 29, 2025 to May 21, 2026).

Clearance details

Applicant
Boston Aesthetics, Inc.
Product code
Product code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wilmington, DE, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.