510(k) · Cleared
ClearedProfile 2000/3000 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- This deviceK040005 Profile 2000/3000 Laser SystemSciton, Inc · 2004
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040005 | Profile 2000/3000 Laser System | Sciton, Inc | 2004 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 8 | 0 |
| 2010 | 17 | 0 |
| 2011 | 18 | 0 |
| 2012 | 18 | 0 |
| 2013 | 16 | 0 |
| 2014 | 24 | 0 |
| 2015 | 26 | 0 |
| 2016 | 34 | 0 |
| 2017 | 30 | 0 |
| 2018 | 31 | 0 |
| 2019 | 14 | 0 |
| 2020 | 35 | 0 |
| 2021 | 28 | 0 |
| 2022 | 45 | 0 |
| 2023 | 34 | 0 |
| 2024 | 63 | 0 |
| 2025 | 63 | 0 |
| 2026 | 38 | 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 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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | 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 5726 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?
- Of its descendants, K042000 (Msq (M2), Ltd., 2004) has gone furthest, with 517 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
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.
https://510kreport.com/device/K040005 · printed Nov 6, 2026
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