# K181480: MMD Tip

- Pathway: 510(k) (Traditional)
- Applicant: Strata Skin Sciences, Inc.
- Decided: Aug 1, 2018 after 57 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: 6 generations back to K885026 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073659: Xtrac Ultra 2, Model AL10000, Photo Medex, Inc. (2008) Summary page 5.

## Indications for use
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.

Source page: https://510kreport.com/device/K181480
Methodology: https://510kreport.com/methodology