# K053527: Spectra Hair Removal Laser

- Pathway: 510(k) (Traditional)
- Applicant: Spectragenics, Inc.
- Decided: Feb 1, 2008 after 774 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: 8 generations back to K950019 (1995). 24 ancestors in all.
169 later devices descend from it; 2 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032846: Spectra Pulsed Diode Laser, Model DR-1, Spectragenics, Inc. (2003) Summary page 1.
- K052848: Spectra Hair Removal Laser, Spectragenics, Inc. (2005). Cleared while this submission was under review Summary page 1.
- K973324: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1997) Summary page 1.
- K982940: Lightsheer Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1999) Summary page 1.
- K001746: Lightsheer Pulsed Diode Array Laser System (Family of Products), Coherent Star (2000) Summary page 1.
- K013028: Palomar SLP 1000, Palomar Medical Products, Inc. (2001) Summary page 1.
- K010580: Palomar SLP 1000, Palomar Medical Technologies, Inc. (2001) Summary page 1.
- K011747: Palomar LC 100 Diode Laser, Palomar Medical Technologies, Inc. (2001) Summary page 1.
- K020849: Apex 800 Laser System, Model Apex 800, Iridex Corp (2002) Summary page 1.
- K030235: F1 Diode Laser System, Opus Medical, Inc. (2003) Summary page 2.
- K020856: Spatouch Photoepilation System, Radiancy (Israel), Ltd. (2002) Summary page 2.
- K030897: Skinstation, Radiancy (Israel), Ltd. (2003) Summary page 2.
- K051671: Radiancy Skinstation with Modified Light Unit Addembly, Radiancy (Israel), Ltd. (2005) Summary page 2.
- K060839: Abc Hair Removal System, Palomar Medical Technologies, Inc. (2006). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K082298: Flash N' GO (2008), 168 descendants of its own
- K090820: Tria Hair Removal Laser System (2009), 167 descendants of its own
- K103184: Silk'n Flash N GO (2010), 148 descendants of its own
- K103560: Shaser Ipl Hair Removal System (2011), 140 descendants of its own
- K120080: Shaser HRS2 Hair Removal System (2012), 135 descendants of its own

## Indications for use
The Spectra Hair Removal Laser System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

Source page: https://510kreport.com/device/K053527
Methodology: https://510kreport.com/methodology