# K152153: MicroSpot Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Dec 11, 2015 after 130 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K943450 (1995). 513 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 520 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081541: Dermablate Effect, Asclepion Laser Technologies GmbH (2009) Summary page 5.
- K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A, Fotona D.D. (2011) Summary page 5.
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece, Fotona D.D. (2014) Summary page 5.

## Most influential descendants
- K210634: MCL 31 Dermablate System (2022), 3 descendants of its own
- K173002: 2940 nm Er:Yag Laser Handpiece (2017), 1 descendant of its own
- K252561: BTL-754FF (2026), 0 descendants of its own
- K241600: Dermablate (2024), 0 descendants of its own
- K213761: Joule diVa System (2022), 0 descendants of its own

## Indications for use
The MicroSpot Handpiece is intended for Dermatological procedures and Skin resurfacing procedures.

Source page: https://510kreport.com/device/K152153
Methodology: https://510kreport.com/methodology