510(k) Report

510(k) · Cleared

Cleared

Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser Systems

K040662510(k) TraditionalCleared Sep 8, 2004180-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

Chattanooga Group · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Sep 8, 2004 after a 180-day review. The FDA summary names no predicate by number. 118 later devices descend from it.

Decided
Sep 8, 2004
Review
180 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
0

118 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2014: 6 descendants cleared2008: 5 descendants cleared2005: 2 descendants cleared2006: 3 descendants cleared2007: 2 descendants cleared2015: 6 descendants cleared2009: 2 descendants cleared2018: 3 descendants cleared2011: 3 descendants cleared2010: 1 descendant cleared2013: 3 descendants cleared2016: 5 descendants cleared2019: 5 descendants cleared2012: 3 descendants cleared2021: 9 descendants cleared2020: 7 descendants cleared2017: 5 descendants cleared2025: 12 descendants cleared2024: 8 descendants cleared2023: 9 descendants cleared2022: 9 descendants cleared2026: 10 descendants cleared200020052010201520202025
  1. This deviceK040662 Vectra Genisys (Module & Transportable) and Intelect XT (Module &…Chattanooga Group · 2004
  2. Descendant · cites it directly · 63 of its ownK070516 PowerlaserPowermedic Aps · 2007
  3. Descendant · 2 generations on · 58 of its ownK083595 EzlaseBiolase Technology, Inc. · 2009
  4. Descendant · 3 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
  5. Descendant · 3 generations on · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
  6. Descendant · 4 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017

Showing 5 of 118 descendants. See all descendants

Descendants cleared per year

2005: 22006: 32007: 22008: 52009: 22010: 12011: 32012: 32013: 32014: 62015: 62016: 52017: 52018: 32019: 52020: 72021: 92022: 92023: 92024: 82025: 122026: 10
2005high 12 (2025) · low 1 (2010)2026

Most influential descendants

Showing 5 of 118 · See all
  • K070516PowerlaserPowermedic Aps · 2007 · cites it directly63descendants
  • K083595EzlaseBiolase Technology, Inc. · 2009 · 2 generations on58descendants
  • K121286EPIC 10Biolase Technology, Inc. · 2012 · 3 generations on31descendants
  • K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · 3 generations on25descendants
  • K170500SIROLaser Advance+Dentsply Sirona · 2017 · 4 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040662Vectra Genisys (Module & Transportable) and Intelect XT (Module &…Chattanooga Group2004—
+1K070516PowerlaserPowermedic Aps2007—
+2K083595EzlaseBiolase Technology, Inc.2009—
+3K121286EPIC 10Biolase Technology, Inc.2012—
+3K123971Cynosure 1064NM Diode LaserCynosure, Inc.2013—
+4K170500SIROLaser Advance+Dentsply Sirona2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200630
200720
200850
200920
201010
201130
201230
201330
201460
201560
201650
201750
201830
201950
202070
202190
202290
202390
202480
2025120
2026100
FIG. 1 — Lineage of K040662, 2004–2026Source: 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), 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 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?

The FDA summary names no predicate by number.

What descends from it? (118)

See all 118

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

NumberDeviceApplicantDecidedDescendants
K070516PowerlaserPowermedic Aps200763
K081962Lapex BCSMeridian Co., Ltd.200819
K132284Vectra Neo Clinical Therapy SystemDjo, LLC201414
K050070K-Laser, Models 3,4,4D,6DEltech S.R.L200512
K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc.20068
K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052
K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc.20081
K150353BTL-4000BTL Industries, Inc.20150
K141564Opton ProZimmer Medizinsystems GmbH20140
K073352Weberneedle Basic LaserWeber Medical GmbH20080

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, K070516 (Powermedic Aps, 2007) has gone furthest, with 63 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—

What is it indicated for?

For Infrared Lamp (Laser)

Vectra Genisys (Intelect XT) Laser Module and Vectra Genisys (Intelect XT) Laser Transportable Systems are indicated for topical heating for:

* temporary increase in local blood circulation

* temporary relief of minor muscle and joint aches, pains and stiffness

* relaxation of muscles

* temporary relief of muscle spasms

* temporary relief of minor pain and stiffness associated with arthritis

Indications for use as stated in the FDA summary.

More from Chattanooga Group

11 FDA decisions under this applicant name. See the company

  • K090632Compex RehabChattanooga Group · 2009
  • K083433Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601Chattanooga Group · 20091 recall
  • K083140Compex Sport PlusChattanooga Group · 2009
  • K070425Vitalstim ExperiaChattanooga Group · 2007
  • K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006

Recent decisions in ILY

The ILY category page

  • K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight…Wuhan PHOMED Technology Company, Ltd. · 2026
  • K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company, Ltd. · 2025
  • K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc. · 2024
  • K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V. · 2023
  • K221189Oliz LTB-1000ALtbio Co., Ltd. · 2022

https://510kreport.com/device/K040662 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040662: Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040662

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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