510(k) Report

510(k) · Cleared

Cleared

Bclear

K020591510(k) TraditionalCleared May 16, 200283-day reviewClass II21 CFR 878.4630

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

Lumenis · FTC Light, Ultraviolet, Dermatological

Cleared on May 16, 2002 as substantially equivalent to K011382 (Photo Medex, Inc., 2001) and 3 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1989. 759 later devices descend from it.

Decided
May 16, 2002
Review
83 days
Class
Class II
Product code
FTC
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K885026 (1989). 7 ancestors in all. 759 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1993: 3 other ancestors2003: 2 descendants cleared2002: 2 descendants cleared2007: 16 descendants cleared2005: 4 descendants cleared2004: 4 descendants cleared2009: 14 descendants cleared2011: 18 descendants cleared2006: 6 descendants cleared2008: 23 descendants cleared2017: 35 descendants cleared2010: 17 descendants cleared2013: 24 descendants cleared2016: 35 descendants cleared2023: 49 descendants cleared2015: 26 descendants cleared2020: 45 descendants cleared2018: 33 descendants cleared2012: 15 descendants cleared2022: 50 descendants cleared2019: 23 descendants cleared2024: 82 descendants cleared2014: 27 descendants cleared2026: 67 descendants cleared2021: 37 descendants cleared2025: 105 descendants clearedK885026 · Houva II Uvb · National Biological Corp. · 1989K992914 · Excimer Laser Phototherapy System, AL7000 · Acculase, Inc. · 20001990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 9 descendants2 generations forward: 16 descendants3 generations forward: 42 descendants4 generations forward: 72 descendants5 generations forward: 92 descendants6 generations forward: 135 descendants7 generations forward: 144 descendants8 generations forward: 123 descendants9 generations forward: 74 descendants10 generations forward: 31 descendants11 generations forward: 13 descendants12 generations forward: 2 descendants13 generations forward: 5 descendants14 generations forward: 1 descendant K992914 · Excimer Laser Phototherapy System, AL7000 · Acculase, Inc. · 2000K885026 · Houva II Uvb · National Biological Corp. · 19890+5+10
  1. Root · 2 generations backK885026 Houva II UvbNational Biological Corp. · 1989
  2. 1 generation backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
  3. This deviceK020591 BclearLumenis · 2002
  4. Descendant · cites it directly · 750 of its ownK021762 BclearLumenis, Inc. · 2002
  5. Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
  6. Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
  7. Descendant · 2 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
  8. Descendant · 2 generations on · 302 of its ownK041969 Aurora DSSyneron Medical, Ltd. · 2004

Showing 5 of 759 descendants. See all descendants

Descendants cleared per year

2002: 22003: 22004: 42005: 42006: 62007: 162008: 232009: 142010: 172011: 182012: 152013: 242014: 272015: 262016: 352017: 352018: 332019: 232020: 452021: 372022: 502023: 492024: 822025: 1052026: 67
2002high 105 (2025) · low 2 (2002)2026

Most influential descendants

Showing 5 of 759 · See all
  • K021762BclearLumenis, Inc. · 2002 · cites it directly750descendants
  • K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
  • K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
  • K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 2 generations on402descendants
  • K041969Aurora DSSyneron Medical, Ltd. · 2004 · 2 generations on302descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K885026Houva II UvbNational Biological Corp.1989—
−1K992914Excimer Laser Phototherapy System, AL7000Acculase, Inc.2000—
0 (this device)K020591BclearLumenis2002—
+1K021762BclearLumenis, Inc.2002—
+1K033946Lovely SystemMsq (M2), Ltd.2004—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004—
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005—
+2K041969Aurora DSSyneron Medical, Ltd.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199330
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200320
200440
200540
200660
2007160
2008230
2009140
2010170
2011180
2012150
2013240
2014270
2015260
2016350
2017350
2018330
2019230
2020450
2021370
2022500
2023490
2024820
20251050
2026670
FIG. 1 — Lineage of K020591, 1989–2026Source: 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 FTC? 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 FTC device

  1. #1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 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? (4)

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
*K011382Xtrac Excimer Laser System, Model AL 7000
Summary page 1
…ent Ultraviolet lamp for dermatologic/skin disorders (see 21 CFR 878.4630). PhotoMedex, the parent of AccuLase, Inc., XTRAC™ Excimer Laser Phototherapy System, AL7000 (K011382; K992914, K003705); Daavlin Co., Psorawand™ (Psoralite; K930856). 20 Korosr T System Description: The BClear,…
Photo Medex, Inc.2001—
*K992914Excimer Laser Phototherapy System, AL7000
Summary page 1
…aviolet lamp for dermatologic/skin disorders (see 21 CFR 878.4630). PhotoMedex, the parent of AccuLase, Inc., XTRAC™ Excimer Laser Phototherapy System, AL7000 (K011382; K992914, K003705); Daavlin Co., Psorawand™ (Psoralite; K930856). 20 Korosr T System Description: The BClear, Targeted…
Acculase, Inc.2000—
*K003705Xtrac Excimer Laser System, Model AL7000
Summary page 1
…amp for dermatologic/skin disorders (see 21 CFR 878.4630). PhotoMedex, the parent of AccuLase, Inc., XTRAC™ Excimer Laser Phototherapy System, AL7000 (K011382; K992914, K003705); Daavlin Co., Psorawand™ (Psoralite; K930856). 20 Korosr T System Description: The BClear, Targeted PhotoClea…
Photo Medex, Inc.2001—
*K930856Psoralite
Summary page 1
…878.4630). PhotoMedex, the parent of AccuLase, Inc., XTRAC™ Excimer Laser Phototherapy System, AL7000 (K011382; K992914, K003705); Daavlin Co., Psorawand™ (Psoralite; K930856). 20 Korosr T System Description: The BClear, Targeted PhotoClearing System, is an ultraviolet light source and…
Daavlin Co.1993—

Also cleared against K011382: 6 other devices →

What descends from it? (759)

See all 759

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

NumberDeviceApplicantDecidedDescendants
K021762BclearLumenis, Inc.2002750
K033946Lovely SystemMsq (M2), Ltd.2004737
K022165Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2Theralight, Inc.2002291
K024020Theralight UV120-2 Uva/Uvb Phototherapy SystemTheralight, Inc.2003289
K040062Levia Phototherapy SystemLerner Medical Devices, Inc.2004280
K051428Vtrac Excimer Lamp SystemPhoto Medex, Inc.2005274
K072035Resolve Uvb Phototherapy SystemAllux Medical20076
K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc20073
K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030

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 3 companies; a new generation was cleared every 10.7 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K021762 (Lumenis, Inc., 2002) has gone furthest, with 750 descendants of its own.
  • 6 other devices also cite its predicate K011382.

How does its category compare?

All FTC devices

FTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTC

3in 2025

2007: 42008: 32009: 22010: 12011: 52012: 12013: 12014: 22015: 32016: 12017: 22018: 32019: 22020: 52021: 32022: 12023: 42024: 12025: 32026 (partial year): 4
2007high 5 (2011) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTC

76in 2025

2007: 53 days median2008: 41 days median2011: 125 days median2015: 98 days median2018: 88 days median2020: 237 days median2021: 89 days median2023: 48 days median2025: 76 days median2026 (partial year): 91 days median
2007high 237 (2020) · low 41 (2008)2026

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

Recalls per year · FTC

3so far in 2026, the most since 2007

2008: 12025: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTC

8in 2025

2010: 22012: 12013: 12014: 12015: 82016: 22017: 22019: 142020: 42021: 482022: 42023: 52024: 42025: 8
2007high 48 (2021) · low 0 (2007)2025

MAUDE reports naming product code FTC, 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
200745300
200834110
20092—00
20101—02
2011512500
20121—01
20131—01
20142—01
201539808
20161—02
20172—02
201838800
20192—014
2020523704
2021389048
20221—04
202344805
20241—04
202537618
20264913—

What is it indicated for?

The BClear™, Targeted PhotoClearing System, is a medical ultraviolet lamp and delivery device that is intended for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema) and seborrheic dermatitis. The BClear, Targeted PhotoClearing System, is intended for use on all skin types (I-VI).

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 K011382

6 other devices cite the same predicate.

  • K073659Xtrac Ultra 2, Model AL10000Photo Medex, Inc. · 2008
  • K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 20072 recalls
  • K041943Xtrac XL, Model AL8000Photo Medex, Inc. · 2004
  • K031451Xtracxl Plus Excimer Laser System, Model AL7000Photo Medex, Inc. · 2003
  • K021762BclearLumenis, Inc. · 2002
  • K020847Xtrac Excimer Laser System, Model AL7000Photo Medex, Inc. · 2002

More from Lumenis

7 FDA decisions under this applicant name. See the company

  • K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis · 20101 recall
  • K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
  • K011197Dermaclear UV-B Phototherapy SystemLumenis · 2001
  • P990049/S001Coherent Opal PhotoactivatorLumenis · 2001
  • K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and…Lumenis · 20012 recalls

Recent decisions in FTC

The FTC category page

  • K262885308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)Guangxi Hope Medical Devices Technology Co., Ltd. · 2026
  • K262285UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)Shijiazhuang Recovery Star Medical Device Co., Ltd. · 2026
  • K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd. · 2026
  • K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC · 2026
  • K250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd. · 2025

https://510kreport.com/device/K020591 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020591: Bclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020591

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