# K952118: ELMER

- Pathway: 510(k) (Traditional)
- Applicant: Biological Technology Corp.
- Decided: Aug 7, 1995 after 94 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971459: Dermalase (1997), 6 descendants of its own
- K052354: Oculase MD (2006), 5 descendants of its own
- K063867: Cutera ER:Ysgg Laser Handpiece (2007), 2 descendants of its own
- K080530: Modification to Cutera ER:Ysgg Laser Handpiece (2008), 1 descendant of its own
- K210183: Waterlase iPLus (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K952118
Methodology: https://510kreport.com/methodology