510(k) Report

510(k) · Cleared

Cleared

Multiwave XR

K051876510(k) AbbreviatedCleared Sep 9, 200560-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

Pacific Quantum Instruments, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Sep 9, 2005 as substantially equivalent to K022951 (Candela Corp., 2003) and 6 other predicates after a 60-day review. Its family tree reaches back 8 generations to 1992.

Decided
Sep 9, 2005
Review
60 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
7

Its longest line of descent runs back 8 generations to K910422 (1992). 105 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 2 other ancestors2003: 3 other ancestors2002: 14 other ancestors2000: 11 other ancestors2001: 12 other ancestors1999: 5 other ancestors1998: 6 other ancestors1997: 10 other ancestors1996: 8 other ancestors1994: 8 other ancestors1995: 6 other ancestors1990: 1 other ancestor1993: 5 other ancestors1991: 4 other ancestors1988: 1 other ancestor1982: 1 other ancestorK910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000K014040 · Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models · Altus Medical, Inc. · 2002K022226 · Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models · Altus Medical, Inc. · 2002K032218 · Adept 1064/532/755 Laser · Adept Medical Concepts · 2003198019851990199520002005
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 18 other ancestors3 generations back: 35 other ancestors4 generations back: 11 other ancestors5 generations back: 9 other ancestors6 generations back: 4 other ancestors7 generations back: 14 other ancestors K032218 · Adept 1064/532/755 Laser · Adept Medical Concepts · 2003K022226 · Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models · Altus Medical, Inc. · 2002K014040 · Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models · Altus Medical, Inc. · 2002K991935 · Epilight Hair Removal System, Photoderm HR System · Esc Medical Systems, Ltd. · 2000K974536 · Photoderm HR System · Esc Medical Systems, Ltd. · 1998K962446 · Sharplan Ruby Laser System · Sharplan Lasers, Inc. · 1997K961279 · Sharplan Lasers, Inc. Ruby Laser System · Sharplan Lasers, Inc. · 1996K910422 · Model RD-1200 Ruby Laser System · Spectrum Medical Technologies, Inc. · 1992−50
  1. Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
  3. 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
  4. 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
  5. 4 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
  6. 3 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  7. 2 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  8. 1 generation backK032218 Adept 1064/532/755 LaserAdept Medical Concepts · 2003
  9. This deviceK051876 Multiwave XRPacific Quantum Instruments, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K910422Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc.1992—
−7K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.1996—
−6K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.1997—
−5K974536Photoderm HR SystemEsc Medical Systems, Ltd.1998—
−4K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.2000—
−3K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
−2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
−1K032218Adept 1064/532/755 LaserAdept Medical Concepts2003—
0 (this device)K051876Multiwave XRPacific Quantum Instruments, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198810
199010
199140
199350
199480
199560
199680
1997100
199860
199950
2000110
2001120
2002140
200330
200420
FIG. 1 — Lineage of K051876, 1992–2005Source: 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 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
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What was it cleared against? (7)

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
*K022951Candela Gentle Yag Laser System, Variable Pulse Yag
Summary page 1
…s II Product Code: GEX - Laser, instrument, surgical, powered Panel: 79 Predicate Devices 1). GentleYAG (Candela), K022951, K023193 2). GentleLASE GL (Candela), K994260 3). Gemini (Laserscope), K034011…
Candela Corp.2003—
*K023193Candela Gentle Yag Laser System
Summary page 1
…Product Code: GEX - Laser, instrument, surgical, powered Panel: 79 Predicate Devices 1). GentleYAG (Candela), K022951, K023193 2). GentleLASE GL (Candela), K994260 3). Gemini (Laserscope), K034011…
Candela Corp.2002—
*K994260Candela Gentlelase GL Dermatological Laser
Summary page 1
…rgical, powered Panel: 79 Predicate Devices 1). GentleYAG (Candela), K022951, K023193 2). GentleLASE GL (Candela), K994260 3). Gemini (Laserscope), K034011 4). Aura i (Laserscope), K024206…
Candela Corp.2000—
*K034011Gemini Surgical Laser System & Accessories
Summary page 1
…ate Devices 1). GentleYAG (Candela), K022951, K023193 2). GentleLASE GL (Candela), K994260 3). Gemini (Laserscope), K034011 4). Aura i (Laserscope), K024206 5). Apogee Elite (Cynosure), K034030…
Laserscope2004—
*K024206Aura Isurgical Laser System & Accessories
Summary page 1
…93 2). GentleLASE GL (Candela), K994260 3). Gemini (Laserscope), K034011 4). Aura i (Laserscope), K024206 5). Apogee Elite (Cynosure), K034030 6). Adept 1064/532/755 Laser (Adept Medical…
Laserscope2003—
*K034030Apogee Elite
Summary page 1
…60 3). Gemini (Laserscope), K034011 4). Aura i (Laserscope), K024206 5). Apogee Elite (Cynosure), K034030 6). Adept 1064/532/755 Laser (Adept Medical Concepts) K032218 Device Description The MultiWave XR c…
Cynosure, Inc.2004—
*K032218Adept 1064/532/755 Laser
Summary page 1
…. Aura i (Laserscope), K024206 5). Apogee Elite (Cynosure), K034030 6). Adept 1064/532/755 Laser (Adept Medical Concepts) K032218 Device Description The MultiWave XR combines three laser outputs in a single device. It produces a…
Adept Medical Concepts2003—

Also cleared against K022951: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
  • 3 of the 105 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K022951.

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 MultiWave AR Laser System is indicated for the following uses: 1. The 532 nm wavelength is indicated for: the treatment of Acne, benign vascular, including telangiectasia on the leg and face. 2. The 755 mm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for T-IV skin types. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 3. The 1064 nm wavelength is indicated…

Read the full statement (113 words)

The MultiWave AR Laser System is indicated for the following uses:

1. The 532 nm wavelength is indicated for: the treatment of Acne, benign vascular, including telangiectasia on the leg and face.

2. The 755 mm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for T-IV skin types. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

3. The 1064 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for IV-VI skin types. It also indicated for photocoagulation and hemostasis of dermatological vascular lesions, for incision/excision of soft body tissues in dermatology, and for nonablative wrinkle reduction.

Indications for use as stated in the FDA summary.

Also cleared against K022951

3 other devices cite the same predicate.

  • K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc. · 2014
  • K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
  • K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003

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/K051876 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051876: Multiwave XR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051876

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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