510(k) Report

510(k) · Cleared

Cleared

Super Nova, Acubeam

K001179510(k) TraditionalCleared Oct 27, 2000199-day reviewClass II21 CFR 890.5500

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

Light Force Therapy, Inc. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Oct 27, 2000 after a 199-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 701 later devices descend from it.

Decided
Oct 27, 2000
Review
199 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
0

701 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2004: 10 descendants cleared2005: 16 descendants cleared2006: 6 descendants cleared2003: 4 descendants cleared2002: 1 descendant cleared2009: 10 descendants cleared2008: 21 descendants cleared2010: 11 descendants cleared2014: 20 descendants cleared2011: 11 descendants cleared2007: 5 descendants cleared2013: 13 descendants cleared2012: 15 descendants cleared2015: 29 descendants cleared2017: 30 descendants cleared2023: 47 descendants cleared2020: 40 descendants cleared2018: 36 descendants cleared2016: 37 descendants cleared2022: 45 descendants cleared2019: 26 descendants cleared2024: 69 descendants cleared2025: 99 descendants cleared2021: 41 descendants cleared2026: 59 descendants cleared200020052010201520202025
  1. This deviceK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
  2. Descendant · cites it directly · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
  3. Descendant · cites it directly · 311 of its ownK023621 Bioflex Professional Therapy SystemMeditech International, Inc. · 2003
  4. Descendant · 2 generations on · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
  5. Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
  6. Descendant · 3 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled

Showing 5 of 701 descendants. See all descendants

Descendants cleared per year

2002: 12003: 42004: 102005: 162006: 62007: 52008: 212009: 102010: 112011: 112012: 152013: 132014: 202015: 292016: 372017: 302018: 362019: 262020: 402021: 412022: 452023: 472024: 692025: 992026: 59
2002high 99 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 701 · See all
  • K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · cites it directly402descendants
  • K023621Bioflex Professional Therapy SystemMeditech International, Inc. · 2003 · cites it directly311descendants
  • K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · 2 generations on294descendants
  • K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
  • K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 3 generations on241descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001179Super Nova, AcubeamLight Force Therapy, Inc.2000—
+1K042630Revlight Skin Care SystemSkincare Technology, Inc.2005—
+1K023621Bioflex Professional Therapy SystemMeditech International, Inc.2003—
+2K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc.2004—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008—
+3K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20041

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200340
2004100
2005160
200660
200750
2008210
2009100
2010110
2011110
2012150
2013130
2014200
2015290
2016370
2017300
2018360
2019260
2020400
2021410
2022450
2023470
2024690
2025990
2026590
FIG. 1 — Lineage of K001179, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ILY? 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 ILY device

  1. #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (701)

See all 701

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

NumberDeviceApplicantDecidedDescendants
K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402
K023621Bioflex Professional Therapy SystemMeditech International, Inc.2003311
K020017Medx 1000 SeriesMedx Electronics, Inc.2002187
K032816Quantum Light Therapy SystemStargate International, Inc.200473
K032787Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies200315
K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP200410
K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc.20068
K052814Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc.20058
K042532Biocare Systems Premir 818Biocare Systems, Inc.20048
K042256IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and…Usa Laser Biotech, Inc.20047

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?

  • Of its descendants, K042630 (Skincare Technology, Inc., 2005) has gone furthest, with 402 descendants of its own.

How does its category compare?

All ILY devices

ILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILY

1in 2025

2007: 102008: 162009: 132010: 82011: 92012: 112013: 92014: 112015: 112016: 82017: 52020: 12022: 22023: 12024: 12025: 12026 (partial year): 1
2007high 16 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILY

116in 2017

2007: 128 days median2008: 165 days median2009: 189 days median2010: 185 days median2011: 198 days median2012: 130 days median2013: 211 days median2014: 153 days median2015: 146 days median2016: 214 days median2017: 116 days median
2007high 214 (2016) · low 116 (2017)2026

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

Recalls per year · ILY

1in 2025

2010: 12012: 32022: 42023: 12025: 12026 (partial year): 1
2007high 4 (2022) · low 0 (2007)2026

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

Adverse event reports per year · ILY

17in 2025

2007: 242008: 202009: 92010: 72011: 102012: 72013: 82015: 22016: 22017: 122018: 12019: 72020: 52021: 52022: 22023: 152024: 192025: 17
2007high 24 (2007) · low 0 (2014)2025

MAUDE reports naming product code ILY, 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
200710128024
200816165020
20091318909
2010818517
20119198010
20121113037
2013921108
20141115300
20151114602
2016821402
20175116012
20180—01
20190—07
20201—05
20210—05
20222—42
20231—115
20241—019
20251—117
20261—1—

More from Light Force Therapy, Inc.

2 FDA decisions under this applicant name. See the company

  • K022888Acubeam, Super Nova, DioLight Force Therapy, Inc. · 2002

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https://510kreport.com/device/K001179 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001179: Super Nova, Acubeam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001179

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026