510(k) Report

510(k) · Cleared

Cleared

Glide Device

K131870510(k) SpecialCleared Aug 14, 201351-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Home Skinovations, Ltd. · OHT Light Based Over-The-Counter Hair Removal

Cleared on Aug 14, 2013 as substantially equivalent to K103184 (Home Skinovations, Ltd., 2010) after a 51-day review. Its family tree reaches back 12 generations to 1995. 33 later devices descend from it.

Decided
Aug 14, 2013
Review
51 days
Class
Class II
Product code
OHT
Recalls
None
Predicates
1

Its longest line of descent runs back 12 generations to K950019 (1995). 41 ancestors in all, the oldest K892514 (1990). 33 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 4 other ancestors2008: 1 other ancestor1999: 2 other ancestors1998: 4 other ancestors1997: 4 other ancestors2005: 1 other ancestor2003: 2 other ancestors2002: 2 other ancestors2001: 4 other ancestors1990: 1 other ancestor1996: 2 other ancestors1992: 1 other ancestor1993: 1 other ancestor2014: 3 descendants cleared2017: 2 descendants cleared2016: 2 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2022: 3 descendants cleared2021: 1 descendant cleared2023: 4 descendants cleared2025: 8 descendants cleared2024: 3 descendants cleared2026: 4 descendants clearedK950019 · Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 · Thermolase Corp. · 1995K963947 · Epilaser Normal Mode Ruby Laser · Spectrum Medical Technologies, Inc. · 1997K973324 · Starlight Pulsed Diode Array Laser System · Star Medical Technologies, Inc. · 1997K982940 · Lightsheer Pulsed Diode Array Laser System · Star Medical Technologies, Inc. · 1999K011747 · Palomar LC 100 Diode Laser · Palomar Medical Technologies, Inc. · 2001K032846 · Spectra Pulsed Diode Laser, Model DR-1 · Spectragenics, Inc. · 2003K052848 · Spectra Hair Removal Laser · Spectragenics, Inc. · 2005K060839 · Abc Hair Removal System · Palomar Medical Technologies, Inc. · 2006K072906 · SILK'N · Home Skinovations, Ltd. · 2008K082298 · Flash N' GO · Home Skinovations, Ltd. · 2008K090820 · Tria Hair Removal Laser System · Spectragenics, Inc. · 2009K103184 · Silk'n Flash N GO · Home Skinovations, Ltd. · 20101990200020102020
  1. Root · 12 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
  2. 8 generations between
  3. 3 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
  4. 2 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
  5. 1 generation backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
  6. This deviceK131870 Glide DeviceHome Skinovations, Ltd. · 2013
  7. Descendant · cites it directly · 23 of its ownK140527 Sensilight MiniEl Global Trade, Ltd. · 2014
  8. Descendant · 2 generations on · 19 of its ownK161565 DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd · 2016
  9. Descendant · cites it directly · 19 of its ownK141242 Glide DeviceHome Skinovations, Ltd. · 2014
  10. Descendant · 3 generations on · 15 of its ownK213041 IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd. · 2021
  11. Descendant · cites it directly · 14 of its ownK140381 Sensilight/ Sensilight PlusEl Global Trade, Ltd. · 2014
Show all 12 generations
  1. Root · 12 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
  2. 11 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
  3. 10 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
  4. 9 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
  5. 8 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
  6. 7 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
  7. 6 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
  8. 5 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
  9. 4 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
  10. 3 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
  11. 2 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
  12. 1 generation backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
  13. This deviceK131870 Glide DeviceHome Skinovations, Ltd. · 2013

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2014: 32016: 22017: 22018: 22019: 12021: 12022: 32023: 42024: 32025: 82026: 4
2014high 8 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 33 · See all
  • K140527Sensilight MiniEl Global Trade, Ltd. · 2014 · cites it directly23descendants
  • K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd · 2016 · 2 generations on19descendants
  • K141242Glide DeviceHome Skinovations, Ltd. · 2014 · cites it directly19descendants
  • K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd. · 2021 · 3 generations on15descendants
  • K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd. · 2014 · cites it directly14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K950019Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Thermolase Corp.1995—
−11K963947Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc.1997—
−10K973324Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.1997—
−9K982940Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc.1999—
−8K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc.2001—
−7K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc.2003—
−6K052848Spectra Hair Removal LaserSpectragenics, Inc.2005—
−5K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc.2006—
−4K072906SILK'NHome Skinovations, Ltd.2008—
−3K082298Flash N' GOHome Skinovations, Ltd.2008—
−2K090820Tria Hair Removal Laser SystemSpectragenics, Inc.2009—
−1K103184Silk'n Flash N GOHome Skinovations, Ltd.2010—
0 (this device)K131870Glide DeviceHome Skinovations, Ltd.2013—
+1K140527Sensilight MiniEl Global Trade, Ltd.2014—
+2K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd2016—
+1K141242Glide DeviceHome Skinovations, Ltd.2014—
+3K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.2021—
+1K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199310
199620
199740
199840
199920
200040
200140
200220
200320
200510
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201430
201620
201720
201820
201910
202110
202230
202340
202430
202580
202640
FIG. 1 — Lineage of K131870, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OHT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OHT device

  1. #1 K221002 IPL Hair Removal Device, Model (s): UI04A…score 36.1 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K103184Silk'n Flash N GO
Summary page 1
…d.: Device Manufacturer 510(k) No. Silk'n Flash N Go Home Skinovations Ltd. K103184 Device Description: The Glide device is a pulsed light hair removal device. Light-based hair removal -is based on…
Home Skinovations, Ltd.2010—

Also cleared against K103184: 6 other devices →

What descends from it? (33)

See all 33

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140527Sensilight MiniEl Global Trade, Ltd.201423
K141242Glide DeviceHome Skinovations, Ltd.201419
K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 41 ancestors has a recall of any class.
  • Of its descendants, K140527 (El Global Trade, Ltd., 2014) has gone furthest, with 23 descendants of its own.
  • 6 other devices also cite its predicate K103184.

How does its category compare?

All OHT devices

OHT Light Based Over-The-Counter Hair Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OHT

25in 2025

2010: 12012: 12013: 22014: 42015: 22016: 32017: 62018: 82019: 72020: 12021: 122022: 252023: 322024: 262025: 252026 (partial year): 11
2007high 32 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OHT

87in 2025

2014: 166 days median2016: 81 days median2017: 87 days median2018: 89 days median2019: 64 days median2021: 89 days median2022: 70 days median2023: 83 days median2024: 62 days median2025: 87 days median2026 (partial year): 84 days median
2007high 166 (2014) · low 62 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OHT

No recall names OHT since 2007.

Adverse event reports per year · OHT

6in 2025

2015: 12016: 22019: 22020: 32021: 12022: 22023: 62025: 6
2007high 6 (2023) · low 0 (2007)2025

MAUDE reports naming product code OHT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20121—00
20132—00
2014416600
20152—01
201638102
201768700
201888900
201976402
20201—03
2021128901
2022257002
2023328306
2024266200
2025258706
202611840—

What is it indicated for?

The GlideTM device is an over the counter device intended for the removal of unwanted hair. The GlideTM device is also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K131870: Glide Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131870

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026