510(k) Report

510(k) · Cleared

Cleared

Laseaway Alexandrite Laser System

K982316510(k) TraditionalCleared Dec 16, 1998167-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

Silver Creek, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Dec 16, 1998 as substantially equivalent to K973354 (Sharplan Lasers, Inc., 1997) and 5 other predicates after a 167-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.

Decided
Dec 16, 1998
Review
167 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K963094 (1996). 8 ancestors in all, the oldest K944090 (1994). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors1994: 2 other ancestors1995: 1 other ancestor1999: 1 descendant clearedK963094 · Cynosure Photogenica LP Dermatological Vascular Lesion Laser · Cynosure, Inc. · 1996×2: 2 generations cleared close together, K971874 (1997), K973354 (1997) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K973354 · Sharplan Epitouch Alexandrite Laser System (5000) · Sharplan Lasers, Inc. · 1997K971874 · Sharplan Epitouch Alexandrite Laser System (5000) · Sharplan Lasers, Inc. · 1997K963094 · Cynosure Photogenica LP Dermatological Vascular Lesion Laser · Cynosure, Inc. · 19960
  1. Root · 3 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
  2. 2 generations backK971874 Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
  3. 1 generation backK973354 Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
  4. This deviceK982316 Laseaway Alexandrite Laser SystemSilver Creek, Inc. · 1998
  5. Descendant · cites it directly · 0 of its ownK990043 Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K990043Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K963094Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc.1996—
−2K971874Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc.1997—
−1K973354Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc.1997—
0 (this device)K982316Laseaway Alexandrite Laser SystemSilver Creek, Inc.1998—
+1K990043Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199510
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K982316, 1996–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 GEX? 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 GEX device

  1. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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
*K973354Sharplan Epitouch Alexandrite Laser System (5000)
Summary page 1
…r System is substantially equivalent to numerous devices that are currently commercially available. These devices include the Sharplan Epitouch Alexandrite Laser System (K973354 and K971874), Medlite/755 Alexandrite Laser System (K961006), and Candella Q-Switched Alexandrite Lasers (K955662, K940173 and K9…
Sharplan Lasers, Inc.1997—
*K971874Sharplan Epitouch Alexandrite Laser System (5000)
Summary page 1
…substantially equivalent to numerous devices that are currently commercially available. These devices include the Sharplan Epitouch Alexandrite Laser System (K973354 and K971874), Medlite/755 Alexandrite Laser System (K961006), and Candella Q-Switched Alexandrite Lasers (K955662, K940173 and K944090). The…
Sharplan Lasers, Inc.1997—
*K961006Medlite/755 Alexandrite Laser System
Summary page 1
…t are currently commercially available. These devices include the Sharplan Epitouch Alexandrite Laser System (K973354 and K971874), Medlite/755 Alexandrite Laser System (K961006), and Candella Q-Switched Alexandrite Lasers (K955662, K940173 and K944090). The LaseAway Alexandrite Laser System is safe and e…
Continuum Biomedical, Inc.1996—
*K955662Candela Q-Switched Alexandrite Lasers
Summary page 1
…include the Sharplan Epitouch Alexandrite Laser System (K973354 and K971874), Medlite/755 Alexandrite Laser System (K961006), and Candella Q-Switched Alexandrite Lasers (K955662, K940173 and K944090). The LaseAway Alexandrite Laser System is safe and effective for the intended purpose of removal of unwant…
Candela Laser Corp.1996—
*K940173Candela Q-Switched Alexandrite Laser
Summary page 1
…he Sharplan Epitouch Alexandrite Laser System (K973354 and K971874), Medlite/755 Alexandrite Laser System (K961006), and Candella Q-Switched Alexandrite Lasers (K955662, K940173 and K944090). The LaseAway Alexandrite Laser System is safe and effective for the intended purpose of removal of unwanted body h…
Candela Laser Corp.1994—
*K944090Candela Alex Lazr Q-Switched Alexandrite Laser
Summary page 1
…Epitouch Alexandrite Laser System (K973354 and K971874), Medlite/755 Alexandrite Laser System (K961006), and Candella Q-Switched Alexandrite Lasers (K955662, K940173 and K944090). The LaseAway Alexandrite Laser System is safe and effective for the intended purpose of removal of unwanted body hair on adult…
Candela Laser Corp.1994—

Also cleared against K973354: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990043Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc.19990

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 2 years and passes through 3 companies; a new generation was cleared every 8 months on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K990043 (Leisegang Medical, Inc., 1999) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K973354.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

The LaseAway Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The LaseAway Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K973354

6 other devices cite the same predicate.

  • K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd. · 2009
  • K042474ARIONWavelight Laser Technologie AG · 2004
  • K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc. · 2004
  • K990119Epi-Star Surgical Laser SysterNidek, Inc. · 2000
  • K984601Candela Gentlelase II Dermatological LaserCandela Corp. · 1999
  • K983977Light Age Epicare Alexandrite LaserLight Age, Inc. · 1999

Recent decisions in GEX

The GEX category page

  • K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)Beijing Sea Heart International Science and Technologyco.Ltd · 2026
  • K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd. · 2026
  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K982316 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982316: Laseaway Alexandrite Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982316

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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