510(k) Report

510(k) · Cleared

Cleared

LightScalpel

K173827510(k) TraditionalCleared Sep 14, 2018270-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

Lightscalpel, LLC · GEX Powered Laser Surgical Instrument

Cleared on Sep 14, 2018 as substantially equivalent to K141658 (Lightscalpel, LLC, 2014) after a 270-day review. Its family tree reaches back 10 generations to 1994.

Decided
Sep 14, 2018
Review
270 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K936109 (1994). 72 ancestors in all, the oldest K822136 (1982). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2012: 2 other ancestors2010: 1 other ancestor1997: 5 other ancestors2009: 1 other ancestor2008: 3 other ancestors2007: 2 other ancestors1996: 6 other ancestors1995: 7 other ancestors2005: 1 other ancestor2002: 3 other ancestors1999: 6 other ancestors1994: 5 other ancestors2001: 2 other ancestors2000: 3 other ancestors1998: 7 other ancestors1990: 1 other ancestor1988: 1 other ancestor1982: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1986: 1 other ancestor1993: 1 other ancestorReference device: K100610 · Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems · Lutronic Corporation · 2011Reference device: K110984 · Slim E30 II CO2 Laser · Lasering S.R.L. · 2011K936109 · Sharplan Model 1120 CO2 Surgical Laser · Sharplan Lasers, Inc. · 1994K960521 · Sharplan Lasers, Inc. Silktouch Flash Scanner · Sharplan Lasers, Inc. · 1996K963339 · Coherent Ultrapulse CO2 Surgical Lasers · Coherent Medical Group · 1997K974789 · Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L · Lumenis, Inc. · 1998K022060 · Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories · Lumenis, Inc. · 2002K030147 · Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers · Lumenis, Ltd. · 2003K040234 · Laserpro CO2 Carbon Dioxide Laser System · Photo Medex, Inc. · 2004K080463 · Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories · Alma Lasers, Ltd. · 2008K103501 · Alma Lasers Pixel CO2 Laser System, Delivery Device and Accessories · Alma Lasers, Inc. · 2011K141658 · Light Scalpel · Lightscalpel, LLC · 201419801990200020102020
  1. Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
  2. 6 generations between
  3. 3 generations backK080463 Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd. · 2008
  4. 2 generations backK103501 Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc. · 2011
  5. 1 generation backK141658 Light ScalpelLightscalpel, LLC · 2014
  6. This deviceK173827 LightScalpelLightscalpel, LLC · 2018
Show all 10 generations
  1. Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
  2. 9 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
  3. 8 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
  4. 7 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
  5. 6 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
  6. 5 generations backK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
  7. 4 generations backK040234 Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc. · 2004
  8. 3 generations backK080463 Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd. · 2008
  9. 2 generations backK103501 Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc. · 2011
  10. 1 generation backK141658 Light ScalpelLightscalpel, LLC · 2014
  11. This deviceK173827 LightScalpelLightscalpel, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K936109Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc.1994—
−9K960521Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc.1996—
−8K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997—
−7K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc.1998—
−6K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device…Lumenis, Inc.2002—
−5K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003—
−4K040234Laserpro CO2 Carbon Dioxide Laser SystemPhoto Medex, Inc.2004—
−3K080463Alma Lasers Thermoxel CO2 Laser System and Delivery Device AccessoriesAlma Lasers, Ltd.2008—
−2K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.2011—
−1K141658Light ScalpelLightscalpel, LLC2014—
0 (this device)K173827LightScalpelLightscalpel, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198610
198810
199010
199110
199210
199310
199450
199570
199660
199750
199870
199960
200030
200120
200230
200510
200720
200830
200910
201010
201220
201410
FIG. 1 — Lineage of K173827, 1994–2018Source: 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? (1)

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
*K141658Light Scalpel
Summary page 8
…Classification: Class II Product Code: GEX 4. Predicate Device(s): 4.1. Primary Predicate Device: LightScalpel LS-1005 / LS-2010 CO2 Laser System; K141658 4.2. Reference Predicate Device: Lutronic eCO2™ Laser System; K100610 4.3. Reference Predicate Device: Lasering MiXto, K110…
Lightscalpel, LLC2014—
†K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation2011—
†K110984Slim E30 II CO2 LaserLasering S.R.L.2011—

Also cleared against K141658: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
  • 1 of the 72 ancestors has a recall of any class.
  • 1 other device also cites its predicate K141658.

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. 2018, this device’s year, is highlighted.

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 LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology. Intended uses specific to the LS-2010 FX and…

Read the full statement (884 words)

The LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology.

Intended uses specific to the LS-2010 FX and LS-2010 DX in fractional mode are indicated by **.

Dermatology / Plastic Surgery:

Ablation, and Vaporization of soft tissue for performance of or treatment of: laser skin resurfacing; laser dermabrasion; laser burn debridement; wrinkles**, rhytids**, and furrows**; textural irregularities**; vascular dyschromia**; and benign pigmented lesions**

Intended uses specific to the LS-2010 SX and LS-2010 DX in surgical mode are listed below.

Dental Surgery:

Gingivectomy — Removal of hyperplasias; gingivoplasty; papillectomy; vestibuloplasty; epulis; sulcular debridement; removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; a heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium).

Oral Surgery:

Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional & excisional); aphthous ulcers (incision & excision); excision & ablation of lesions, benign lesions, oral cavity tumors, and hemangiomas; salivary gland pathologies; preprosthetic gum preparation, leukoplakia; partial glossectomy; periodontal gum resection; homeostasis; operculectomy; crown lengthening (soft tissue); incision of infection when used with antibiotic therapy.

General and Thoracic Surgery:

Incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures for: debridement of decubitus ulcers, stasis, diabetic, and other ulcers; mastectomy; debridement of burns; rectal and anal hemorrhoidectomy; breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease, laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts, including sebaceous and pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications.

Dermatology / Plastic Surgery:

Incision, Excision, Ablation, and Vaporization of soft tissue for performance of or treatment of: laser skin resurfacing; laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; textural irregularities; keratosis, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheci wart, and verruca seborrheica; vermillionectomy of the lip; cutaneous horns; solar/actinic elastosis; cheilitis, including actinic cheilitis; lentigines, including lentigo maligna or Hutchinson’s freckle; uneven pigmentation/vascular dyschromia;; surgical scars; keloids, including acne keloidalis nuchae; hemangiomas, including Buccal, port wine, and pyogenic granulomas/granuloma, pyogenicum/granuloma telagiectaticum; tattoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; benign pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; rhinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal & squamous cell carcinoma, including keratoacanthomas, Bowen’s disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; nevi, including spider, epidermal, and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; xanthelasma palpebrarum; syringoma; complete or partial nail matrixectomy; benign vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including: paronychial, periungal, and subungual warts; blepharoplasty; and hair transplantation site preparation.

Gynecology / Genitourinary:

Incision, excision, ablation, and/or vaporization of soft tissue for treatment of: Conization of the cervix, including cervical intraepithelial neoplasia and vulvar and vaginal intraepithelial neoplasia; Condyloma, including cervical, genital, vulvar, perineal, and Bowenoid papulosa; leukoplakia (vulvar dystrophies); incision and drainage of Bartholin’s and nabothian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign tumors; hemangiomas; benign lesions of external genitalia; condyloma; phimosis; erythroplasia.

Gyn Laparoscopic Surgery:

Laser incision, excision, vaporization, and photocoagulation of soft tissue for treatment of: endometrial lesions, including ablation for endometriosis; excision/lysis of adhesions; salpingotomy; oophorectomy/ovariectomy; fimbrioplasty; metroplasty; uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.

Otorhinolaryngology / ENT:

Laser incision, excision, ablation, vaporization, and / or photocoagulation of soft tissue in otorhinolaryngology for treatment of: leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue; adult and juvenile papillomatosis polyps; lymphangioma removal; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis and neoplasma) and tonsil ablation / tonsillotomy; benign tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatitis nondularis chronica helices / Winkler’s disease; uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction / ablation; septal spur ablation/reduction and septoplasty; partial glossectomy; tumor resection of oral, subfacial, and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty / gingivectomy

Podiatry:

Laser excision, ablation, and /or vaporization of soft tissue in podiatry for the reduction, removal and/or treatment of Verrucae vulgares / plantar warts, including paronychial, periungual, and subungual warts; fungal nail treatment; matrixectomy — partial and complete; porokeratoma ablation; neuromas/fibromas, including Morton’s neuroma removal; ingrown toenail treatment; debridement of ulcers; treatment of other soft tissue lesions

Orthopedic Surgery:

Laser incision / excision, ablation, and /or vaporization of soft tissue in orthopedic surgery. Applications include: meniscectomy; chondromalacia ablation; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy; debridement of traumatic wounds; debridement of decubitus & diabetic ulcers; and PMMA removal.

Neurosurgery:

Laser incision / excision, ablation, and /or vaporization of soft tissue in neurosurgery for the treatment of: posterior fossa tumors; peripheral neurectomy; benign tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors); arteriovenous malformation; and pituitary gland tumors (transphenoidal approach).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K173827: LightScalpel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173827

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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