510(k) · Cleared
ClearedBWF-5 Medical Laser Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Litecure, LLC · GEX Powered Laser Surgical Instrument
Cleared on May 12, 2010 as substantially equivalent to K053540 (Intermedic Arfran, SA, 2006) and 8 other predicates after a 223-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- May 12, 2010
- Review
- 223 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 17 generations to K943450 (1995). 392 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 2 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 1 generation backK082263 Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc. · 2008
- This deviceK093087 BWF-5 Medical Laser SeriesLitecure, LLC · 2010
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 3 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 2 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 1 generation backK082263 Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc. · 2008
- This deviceK093087 BWF-5 Medical Laser SeriesLitecure, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −4 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −3 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −2 | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| −1 | K082263 | Ceralas E 980NM Diode Laser, Models E15/980 and E30/980 | Biolitec, Inc. | 2008 | — |
| 0 (this device) | K093087 | BWF-5 Medical Laser Series | Litecure, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 7 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 19 | 0 |
| 1995 | 17 | 0 |
| 1996 | 24 | 0 |
| 1997 | 28 | 0 |
| 1998 | 25 | 0 |
| 1999 | 22 | 0 |
| 2000 | 32 | 0 |
| 2001 | 30 | 0 |
| 2002 | 37 | 0 |
| 2003 | 39 | 0 |
| 2004 | 25 | 0 |
| 2005 | 17 | 0 |
| 2006 | 8 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Summary page 1…eries Classification Laser surgical instrument for use in general and plastic surgery and in dermatology, 21 CER 878.481 0 Predicate Device *K053540 INTERnmedic Arfran, S.A., INTERmedic Diode Laser Family 8 10 rnn and 980 nin and the delivery acce… | 2006 |
| * | K082263 | Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Summary page 1…LTIDIODE PL3DTM, ContrAgeTm, RE ContrAgeT-m,MULTID]ODE VARIUSTM, VRI000OTh, MULTIDIODE ODONTTM; *K082263 Biolitec, Inc., Ceralas E 980nm Diode Laser (Models E15/980, E30/980); *K083613 Q… | 2008 |
| * | K083613 | Quanta System Polysurge Diode Laser FamilySummary page 1…LTIDIODE ODONTTM; *K082263 Biolitec, Inc., Ceralas E 980nm Diode Laser (Models E15/980, E30/980); *K083613 QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY; * K060304 BioTex, Inc., PhoTex 15 Diode… | 2008 |
| * | K060304 | Photex Diode Laser Series, Models 980, 810 and 940Summary page 1…s E15/980, E30/980); *K083613 QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY; * K060304 BioTex, Inc., PhoTex 15 Diode Laser Series: 810, 940, 980, market clearance date March 21, 2006; and… | 2006 |
| * | K972575 | 800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery…Summary page 1…* K060304 BioTex, 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 Fa… | 1998 |
| * | K062363 | BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMSummary page 1…Surgical Laser System Angled Delivery Devices (ADD Family Product Line), market clearance date July 17, 1998. * K062363 B&W Tek, Inc., BVWE-5 Medical Laser Series. * K060033 Sciton, Inc., Profile Multi-Platform System.… | 2007 |
| * | K060033 | Profile Multi-Platform SystemSummary page 1…Product Line), market clearance date July 17, 1998. * K062363 B&W Tek, Inc., BVWE-5 Medical Laser Series. * K060033 Sciton, Inc., Profile Multi-Platform System. * K071295 Biolitec, Inc., 100OW CERALAS D 980NM DIODE LASER… | 2006 |
| * | K071295 | 100W Ceralas D 980NM Diode LaserSummary page 1…* K062363 B&W Tek, Inc., BVWE-5 Medical Laser Series. * K060033 Sciton, Inc., Profile Multi-Platform System. * K071295 Biolitec, Inc., 100OW CERALAS D 980NM DIODE LASER * K070388 Sciton, Inc., Profile Multi-Platform System I… | 2007 |
| * | K070388 | Profile Multi-Platform SystemSummary page 1…* K060033 Sciton, Inc., Profile Multi-Platform System. * K071295 Biolitec, Inc., 100OW CERALAS D 980NM DIODE LASER * K070388 Sciton, Inc., Profile Multi-Platform System Intended Use The BWF-5 Medical Laser Series (8lOrnm, 930nnm, 980nm, lOS0nm… | 2007 |
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 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 19 of the 392 ancestors have a recall of any class.
- 7 other devices also cite its predicate K053540.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The BWF-5 Medical Laser Series (81 Onmn, 930nnm, 9S0nm, lOS0nm and 1320nmn) 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…
Read the full statement (149 words)
The BWF-5 Medical Laser Series (81 Onmn, 930nnm, 9S0nm, lOS0nm and 1320nmn) 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.
The device is specifically indicated for use as follows:
LASER 980nm:
Indicated for use With the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
LASER 1320nm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093087 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093087: BWF-5 Medical Laser Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093087
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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