# K132286: Hyperion Long Pulsed ND: Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Scarlet Rf, Inc.
- Decided: Jan 22, 2014 after 183 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: 11 generations back to K943450 (1995). 148 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022951: Candela Gentle Yag Laser System, Variable Pulse Yag, Candela Corp. (2003) Summary page 1.
- K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2,, Fotona D.D. (2009) Summary page 1.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.

## Most influential descendants
- K202288: Finebeam (2021), 2 descendants of its own
- K260256: Q-Switched Nd: YAG Laser Systems (2026), 0 descendants of its own
- K243780: HELIOS 785 Pico (1754V2) (2025), 0 descendants of its own

## Indications for use
Treatment of wrinkles Removal of unwanted hair far stable long term or *permanent hair reduction Treatment of PFS (pseudofolliculitis barbae) Surgical incision, excision vaporization, ablation and coagulation of soft tissue Photocoagulation and hemostasis of pigmented and vascular lesions in dermatology *Permanent hair reduction isdefined as the long-term stable reduction in the number of hair re-grown when measured at 6, 9,and 12 months after the completion of a treatment regimen.

Source page: https://510kreport.com/device/K132286
Methodology: https://510kreport.com/methodology