510(k) · Cleared
ClearedBclear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · FTC Light, Ultraviolet, Dermatological
Cleared on Aug 23, 2002 as substantially equivalent to K011197 (Lumenis, 2001) and 4 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1989. 750 later devices descend from it.
- Decided
- Aug 23, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K885026 (1989). 9 ancestors in all. 750 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK885026 Houva II UvbNational Biological Corp. · 1989
- 2 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- 1 generation backK020591 BclearLumenis · 2002
- This deviceK021762 BclearLumenis, Inc. · 2002
- Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · 2 generations on · 302 of its ownK041969 Aurora DSSyneron Medical, Ltd. · 2004
- Descendant · 3 generations on · 301 of its ownK050796 Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005
Showing 5 of 750 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 750 · See all- K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 2 generations on402descendants
- K041969Aurora DSSyneron Medical, Ltd. · 2004 · 2 generations on302descendants
- K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd. · 2005 · 3 generations on301descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K885026 | Houva II Uvb | National Biological Corp. | 1989 | — |
| −2 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| −1 | K020591 | Bclear | Lumenis | 2002 | — |
| 0 (this device) | K021762 | Bclear | Lumenis, Inc. | 2002 | — |
| +1 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +2 | K041969 | Aurora DS | Syneron Medical, Ltd. | 2004 | — |
| +3 | K050796 | Aurora DS, DS Applicator | Syneron Medical, Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 15 | 0 |
| 2008 | 23 | 0 |
| 2009 | 14 | 0 |
| 2010 | 17 | 0 |
| 2011 | 17 | 0 |
| 2012 | 15 | 0 |
| 2013 | 24 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 35 | 0 |
| 2017 | 35 | 0 |
| 2018 | 33 | 0 |
| 2019 | 23 | 0 |
| 2020 | 44 | 0 |
| 2021 | 37 | 0 |
| 2022 | 50 | 0 |
| 2023 | 48 | 0 |
| 2024 | 82 | 0 |
| 2025 | 105 | 0 |
| 2026 | 66 | 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 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 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K011197 | Dermaclear UV-B Phototherapy System | 2001 |
| * | K020591 | BclearSummary page 1…Lumenis Inc., BClear, Targeted Photoclearing System (KO1 1197, K020591); PhotoMedex, the parent of AccuLase, Inc., XT… | 2002 |
| * | K011382 | Xtrac Excimer Laser System, Model AL 7000 | 2001 |
| * | K992914 | Excimer Laser Phototherapy System, AL7000Summary page 1…XTRACTMExcimer Laser Phototherapy System, AL7000 (KO1 1382, K992914, K003705). System Description: The BClear, Targeted Photoclearing System, is… | 2000 |
| * | K003705 | Xtrac Excimer Laser System, Model AL7000Summary page 1…XTRACTMExcimer Laser Phototherapy System, AL7000 (KO1 1382, K992914, K003705). System Description: The BClear, Targeted Photoclearing System, is… | 2001 |
What descends from it? (750)
See all 7505 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K033946 (Msq (M2), Ltd., 2004) has gone furthest, with 737 descendants of its own.
- 2 other devices also cite its predicate K011197.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTC
76in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTC
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTC
8in 2025
MAUDE reports naming product code FTC, 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 | 4 | 53 | 0 | 0 |
| 2008 | 3 | 41 | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 5 | 125 | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 98 | 0 | 8 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 3 | 88 | 0 | 0 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 5 | 237 | 0 | 4 |
| 2021 | 3 | 89 | 0 | 48 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 4 | 48 | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 76 | 1 | 8 |
| 2026 | 4 | 91 | 3 | — |
What is it indicated for?
The BClear, Targeted PhotoClearing System, is a medical ultraviolet lamp and delivery device intended for the treatment of leukoderma. The BClear, Targeted PhotoClearing System, is also indicated 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 as stated in the FDA summary.
https://510kreport.com/device/K021762 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021762: Bclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021762
Report an extraction error
Are you the manufacturer?
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