510(k) Report

510(k) · Cleared

Cleared

Profile 2000/3000 Laser System

K040005510(k) TraditionalCleared Mar 29, 200487-day reviewClass II21 CFR 878.4810

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

Sciton, Inc · GEX Powered Laser Surgical Instrument

Cleared on Mar 29, 2004 after an 87-day review. The FDA summary names its predicate without a number. 572 later devices descend from it.

Decided
Mar 29, 2004
Review
87 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

572 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 3 descendants cleared2005: 3 descendants cleared2009: 8 descendants cleared2007: 8 descendants cleared2008: 15 descendants cleared2010: 17 descendants cleared2015: 26 descendants cleared2013: 16 descendants cleared2022: 45 descendants cleared2011: 18 descendants cleared2016: 34 descendants cleared2023: 34 descendants cleared2020: 35 descendants cleared2017: 30 descendants cleared2018: 31 descendants cleared2012: 18 descendants cleared2019: 14 descendants cleared2024: 63 descendants cleared2014: 24 descendants cleared2025: 63 descendants cleared2021: 28 descendants cleared2026: 38 descendants cleared200020052010201520202025
  1. This deviceK040005 Profile 2000/3000 Laser SystemSciton, Inc · 2004
  2. Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
  3. Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
  4. Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
  5. Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
  6. Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009

Showing 5 of 572 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 32007: 82008: 152009: 82010: 172011: 182012: 182013: 162014: 242015: 262016: 342017: 302018: 312019: 142020: 352021: 282022: 452023: 342024: 632025: 632026: 38
2004high 63 (2024) · low 1 (2004)2026

Most influential descendants

Showing 5 of 572 · See all
  • K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
  • K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
  • K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
  • K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
  • K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040005Profile 2000/3000 Laser SystemSciton, Inc2004—
+1K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008—
+1K060033Profile Multi-Platform SystemSciton, Inc2006—
+2K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200630
200780
2008150
200980
2010170
2011180
2012180
2013160
2014240
2015260
2016340
2017300
2018310
2019140
2020350
2021280
2022450
2023340
2024630
2025630
2026380
FIG. 1 — Lineage of K040005, 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 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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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? (8)

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
*—Trimedyne Holmium Laser System
Named without a submission number
—
*—Surgical Laser Technologies LaserPro CTH Holmium Laser System
Named without a submission number
—
*—Lumenis VersaPulse Holmium and Dual Wavelength Surgical Lasers & Delivery Devices with…
Named without a submission number
—
*—New Star Holmium Laser System
Named without a submission number
—
*—Erbium 2000 Laser Family
Named without a submission number
—
*—FutureLase 3000/3002 Erbium Laser System
Named without a submission number
—
*—Schwartz Electro-Optics CLR 2940 Erbium CrystaLase
Named without a submission number
—
*—Laserscope VELA Erbium:YAG Laser System and Accessories
Named without a submission number
—

What descends from it? (572)

See all 572

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

NumberDeviceApplicantDecidedDescendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517
K060033Profile Multi-Platform SystemSciton, Inc2006221
K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160
K050317Burane XLWavelight Laser Technologie AG200553
K052806BuraneWavelight Laser Technologie AG200552
K082947Lensx 550 Laser SystemLensx Lasers, Inc.200951

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, K042000 (Msq (M2), Ltd., 2004) has gone furthest, with 517 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

The Profile 2000 Laser System, and Delivery Devices and Accessories, is indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications: Dermatoloqv and Plastic.Surgery Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic…

Read the full statement (691 words)

The Profile 2000 Laser System, and Delivery Devices and Accessories, is indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications:

Dermatoloqv and Plastic.Surgery

Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns. papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization.

Gastroenteooical/Graostrointestinal Surqer

Gastroenterologic surgery of soft tissue, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer. gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.

Geeneral Surger

General surgery of soft tissues, including; skin incision, tissue dissection, excision of external tumnors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectomy, hepatectomy, pancreatectomy, splenectomy. thyroidectomy, parothyroidectomy, herniorrhaphy, tonsillectomy, lymphadenectomy, partial nephuectomy, pilonidal cystectomy, resection of lipoma, pelvc adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectomy, pytorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectomy.

Genitourinarv SurciervlUrology

Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors: superficial urinary bladder tumors; invasive bladder carcinomas;, urethral and penile hemangiomna; urethral strictures; lesions of the extemnal genitalia; condylornas; bladder neck obstructions. Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hernostasis, vaporization and excision for treatment of benign prostatic hypertrophy.

-PyncociaSuer

Gynecological surgery Of Soft tissue, including condyloma acurninata.

Lithotripsv and _PercutaneusUrnaryLLthotrinsy

Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of uninary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide woires cannot be passed.

Lumbar DiscectpMy

Lumbar discectomy in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.6-SI lumbar discs of the vertebral spine; open, percutaneous and endos-copic spine procedures; foraminotomy.

Ortho~eclJp Surgery

Orthopedic surgery in soft and cartilaginous tissue in small and large joints (excluding the spine), including: knee Meniscectomy, knee synovectomy, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridernent of inflamed synovial tissue, loose body debridemnent, capsulectomny in the knee, chondroplasty in the knee, chondromalacia ablation.

Otorhinolarvriooial(NISurgM

Otorbinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including. endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomny), dacryocystorhinostomy (DCR), ethmoidectormy, polypectomy, maxillary antrotorny, frontal sinusotomy, sphenoidotomny, hereditary hemorrhagic telangectasia, septoplasty.

Pulmonar- Su~rgery

Open and endoscopic pulmonary surgery.

The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands.

Aesthe~tic Surget

Skin resurfacing and treatment of wrinkles.

Deertooy&PatcSrg~y

Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids. verrucae. skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers.

Gastroenterology.

General Surgery

The Erbium;YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation.

GenjtpurinaryUmlog~y_

Gvnecolgy

Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.

.phthalmolg.

Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.

Oral/Maxillofacial

Otorhinolarriaog~oica4l (ENT) Sqrlery

Podjqatr

Indications include warts, plantar verruae, large mosaic verrucae and matrixectomy.

Pulmonary Surciery

Thoracic Suraery

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K040005: Profile 2000/3000 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040005

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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