510(k) Report

510(k) · Cleared

Cleared

BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM

K062363510(k) TraditionalCleared Jan 17, 2007160-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

B&W Tek, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jan 17, 2007 as substantially equivalent to K060304 (Biotex, Inc., 2006) and 1 other predicate after a 160-day review. Its family tree reaches back 2 generations to 1991. 11 later devices descend from it.

Decided
Jan 17, 2007
Review
160 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K912538 (1991). 7 ancestors in all. 11 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor2010: 2 descendants cleared2007: 1 descendant cleared2008: 2 descendants cleared2009: 1 descendant cleared2024: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2018: 1 descendant clearedK912538 · KTP/Yag Plus · Laserscope · 1991K972575 · 800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices · Laserscope · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants K972575 · 800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices · Laserscope · 1998K912538 · KTP/Yag Plus · Laserscope · 19910
  1. Root · 2 generations backK912538 KTP/Yag PlusLaserscope · 1991
  2. 1 generation backK972575 800 Series Surgical Laser System Orion Series Surgical Laser System…Laserscope · 1998
  3. This deviceK062363 BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMB&W Tek, Inc. · 2007
  4. Descendant · cites it directly · 7 of its ownK082721 Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
  6. Descendant · 3 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
  7. Descendant · 2 generations on · 0 of its ownK243141 Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D…Jiangxi Medex Technology Co., Ltd. · 2024
  8. Descendant · 3 generations on · 0 of its ownK191349 980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 12010: 22015: 12018: 12019: 12024: 12025: 1
2007high 2 (2008) · low 0 (2011)2026

Most influential descendants

Showing 5 of 11 · See all
  • K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008 · cites it directly7descendants
  • K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · 2 generations on3descendants
  • K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd. · 2025 · 3 generations on0descendants
  • K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd. · 2024 · 2 generations on0descendants
  • K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K912538KTP/Yag PlusLaserscope1991—
−1K972575800 Series Surgical Laser System Orion Series Surgical Laser System Angled…Laserscope1998—
0 (this device)K062363BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMB&W Tek, Inc.2007—
+1K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.20081
+2K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.2015—
+3K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems…Wuhan Dimed Laser Technology Co., Ltd.2025—
+2K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810)…Jiangxi Medex Technology Co., Ltd.2024—
+3K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199410
199510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200910
201020
201510
201810
201910
202410
202510
FIG. 1 — Lineage of K062363, 1991–2025Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K060304Photex Diode Laser Series, Models 980, 810 and 940
Summary page 1
…ion Laser surgical instrument for use in general and plastic surgery and in ______________dermatology, 21 CER 878.481 0 Predicate: K060304 BioTex, Inc., PhoTex 15 Diode Laser Series: 810, 940, 980, * market clearance d…
Biotex, Inc.2006—
*K972575800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery…
Summary page 1
…ex, Inc., PhoTex 15 Diode Laser Series: 810, 940, 980, * market clearance date March 21, 2006; and K972575 Laserscope, 800 Series Surgical Laser System Orion Surgical Laser System Angled Delivery Devices (ADD Family…
Laserscope1998—

Also cleared against K060304: 4 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.20087
K093087BWF-5 Medical Laser SeriesLitecure, LLC20100
K082445CURATIVE980 Diode LaserOroscience, Inc.20080
K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070

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 16 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K082721 (Photo Medex, Inc., 2008) has gone furthest, with 7 descendants of its own.
  • 4 other devices also cite its predicate K060304.

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. 2007, this device’s year, is highlighted.

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 BWAF-5 Medical Laser Series are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery.

Indications for use as stated in the FDA summary.

Also cleared against K060304

4 other devices cite the same predicate.

  • K093087BWF-5 Medical Laser SeriesLitecure, LLC · 2010
  • K092197PHOTEX30 Diode Laser Series: 980, 810, 940Biotex, Inc. · 2009
  • K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc. · 2007
  • K071328Visualase Thermal Therapy SystemBiotex, Inc. · 20071 recall

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/K062363 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062363: BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062363

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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