(270 days)
No
The summary describes a standard CO2 laser system for surgical procedures. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
This device is a therapeutic device because its intended use is for laser surgery procedures, which involve cutting, excising, vaporizing, and/or coagulating soft tissue to treat various medical conditions across multiple specialties. This directly involves treating or managing patient health conditions.
No
Explanation: The device is a CO2 laser system intended for surgical procedures involving incision, excision, vaporization, and coagulation of soft tissue. Its described functions are all therapeutic, not diagnostic.
No
The device description clearly outlines a physical laser system with hardware components such as a CO2 laser tube, fiber waveguide, handpiece assembly, touch-screen display panel, safety features, and mobility features. While it has a touch-screen display for control, the core function and components are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LightScalpel LS-2010 SX, LS-2010 DX CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, and/or coagulation of soft tissue. This describes a therapeutic or surgical intervention performed directly on a patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description: The device description details a laser system that delivers energy to soft tissue via a fiber waveguide and handpiece. This is consistent with a surgical device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the LightScalpel LS-2010 SX, LS-2010 DX CO2 Laser Systems are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
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, 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 dermabrasion: laser burn debridement; wrinkles*, 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 no the root surface in the absence of long junctional epithelium).
Oral Surgery:
Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional); 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 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 hemorrhoidectorny; 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 sebortheic keratosis, sebortheci wart, and verruca seborrheica; vermillionecomy 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 granuloma, pyogenicum/granuloma telagiectatioum; tattoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; benign pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; thinophyma 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-epitheliomas; xanthelasma palpebrarum; syringoma; complete or partial natrixectomy; benign vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including; paronychial, periungual 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; 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, larynx, pharynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsiller cryptolysis and neoplasma) and topsil ablation / tonsillotomy; benign tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatits nondularis chronica helices / Winkler's disease;
uvulopalatoplasty (LAUP, laser UPPP); 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 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: meniscectorny; 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).
Product codes
GEX
Device Description
The LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX laser systems are mobile platforms that utilize a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength. Output parameters are summarized in Table 1. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. A "calibration port" on the side of the laser systems allows checking and setting the power emitted from the distal laser aperture to the internal power meter and serves as a check on fiber waveguide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below (7): The laser systems have safety features complying with requirements in 21 CFR 1040. Performance Standards for Light Emitting Products. Primary safety features are as follows: System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling. Laser system physical characteristics are: Delivery System: LS-2010 SX, Flexible Fiber Waveguide; ~ 0.75mm ID, Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips. LS-2010 FX & DX; Flexible Fiber Waveguide; ~ 0.50mm ID, Handpiece with internal beam steering galvanometers and laser diode aiming beam. Purge Gas: Internal air pump purge through the Fiber and Handpiece. System Cooling: Air; two thermostatically controlled fans with over-temperature protection. Mobility: 4 wheels and handgrip on console for convenient system positioning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, cervix, vulvar, vaginal, perineal, external genitalia, endometrial, adhesions, salpingotomy, myomas, fibroids, ovarian fibromas, follicle cysts, uterosacral ligament, oral, larynx, uvula, palatal, upper lateral pharyngeal tissue, nasal cavity, tongue, vocal cords, ear, subfacial, neck tissues, plantar, paronychial, periungal, subungual, nail, menisectomy, chondromalacia, chondroplasty, ligament, plica, synovectomy, traumatic wounds, decubitus & diabetic ulcers, posterior fossa, peripheral nerve, pituitary gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data: Each LS-2010 Series laser system is tested for electrical safety and output characteristics. Representative data sheets are presented in the Bench Testing section of this report. Clinical performance data: None. Clinical testing was determined to be unnecessary, as the performance parameters are consistent with predicate CO2 laser systems and technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.
September 14, 2018
LightScalpel LLC David Walters General Manager 11818 North Creek Parkway N Suite 100 Bothell, Washington 98011
Re: K173827
Trade/Device Name: LightScalpel® LS 2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 7, 2018 Received: August 13, 2018
Dear David Walters:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173827
Device Name
LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems
Indications for Use (Describe)
The LightScalpel LS-2010 SX, LS-2010 DX CO2 Laser Systems are intended for use intended for use in laser surgery procedures for incision, excision, vaporization, 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 dermabrasion: laser burn debridement; wrinkles*, and furrows**; textural irregularities**; vascular dyschromia**; and benign pigmented lesions **
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173827
Device Name
LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems
Indications for Use (Describe)
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 no the root surface in the absence of long junctional epithelium).
Oral Surgery:
Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional); 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 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 hemorrhoidectorny; 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.
| and the program of the commends from the commends them the commend of the comments of the comments of the many of the many of the many of the many of the many of the many of | ensions of the considerary contraction of the cities of the cities and in a b | ||
|---|---|---|---|
| Type of Use (Select one or both, as applicable) |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173827
Device Name
LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems
Indications for Use (Describe)
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 sebortheic keratosis, sebortheci wart, and verruca seborrheica; vermillionecomy 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 granuloma, pyogenicum/granuloma telagiectatioum; tattoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; benign pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; thinophyma 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-epitheliomas; xanthelasma palpebrarum; syringoma; complete or partial natrixectomy; benign vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including; paronychial, periungual 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Comments of the State Children Court |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173827
Device Name LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems
Indications for Use (Describe)
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; 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, larynx, pharynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsiller cryptolysis and neoplasma) and topsil ablation / tonsillotomy; benign tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatits nondularis chronica helices / Winkler's disease;
uvulopalatoplasty (LAUP, laser UPPP); 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 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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173827
Device Name LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser Systems
Indications for Use (Describe)
Orthopedic Surgery:
Laser incision / excision, ablation, and /or vaporization of soft tissue in orthopedic surgery. Applications include: meniscectorny; 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).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
Image /page/7/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the word "Scalpel" is in a regular font. A curved line starts at the top of the "S" in "Scalpel" and extends down to the bottom left, where it ends in a starburst symbol. The logo is simple and modern, with a focus on the brand name.
VOL_007 - 510(k) Summary
510(k) Summary Preparation Date: 13 September 2018
-
- 510(K) Owner:
LightScalpel® LLC 11818 North Creek Parkway N, Suite 100 Bothell, WA 98011 866-697-7548 / 425-368-1588 / 425-368-1568 (FAX)
- 510(K) Owner:
-
- 510(k) Contact:
David Walters General Manager 11818 North Creek Parkway N, Suite 100 Bothell, WA 98011 866-697-7548 / 425-368-1588 x472 / 425-368-1568 (FAX) dwalters@lightscalpel.com
- 510(k) Contact:
-
- Device Trade Name: LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser System
Common Name: CO2 Laser System
- Device Trade Name: LightScalpel® LS-2010 SX, LS-2010 FX, and LS-2010 DX CO2 Laser System
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810).
"A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide."
Classification: Class II
Product Code: GEX
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- Predicate Device(s):
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Image /page/8/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, black font, and the word "Scalpel" is in a regular, black font. A curved line extends from the "t" in "light" and arches over the word "Scalpel". A star-like symbol is located below the word "light".
- Device Description and Function 5.
The LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX laser systems are mobile platforms that utilize a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength. Output parameters are summarized in Table 1. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel.
A "calibration port" on the side of the laser systems allows checking and setting the power emitted from the distal laser aperture to the internal power meter and serves as a check on fiber waveguide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below (7):
The laser systems have safety features complying with requirements in 21 CFR 1040. Performance Standards for Light Emitting Products.
Primary safety features are as follows:
System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling.
Laser system physical characteristics are: Delivery System:
LS-2010 SX, Flexible Fiber Waveguide; ~ 0.75mm ID, Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips.
LS-2010 FX & DX; Flexible Fiber Waveguide; ~ 0.50mm ID, Handpiece with internal beam steering galvanometers and laser diode aiming beam.
Purge Gas: Internal air pump purge through the Fiber and Handpiece.
System Cooling: Air; two thermostatically controlled fans with over-temperature protection.
Mobility: 4 wheels and handgrip on console for convenient system positioning.
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Image /page/9/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold font, and the word "Scalpel" is in a regular font. A curved line starts from the top of the "l" in "light", goes over the word "Scalpel", and ends with a starburst symbol below the word "light".
6. Intended use(s) of the Device
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, 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 bv **.
Dermatology / Plastic Surgery:
Ablation and Vaporization of soft tissue for performance of or treatment of: laser skin resurfacing; laser dermabrasion; laser burn debridement; wrinkles**, and furrows**; textural irreqularities*; vascular dyschromia**; and benign pigmented lesions**;
Intended uses specific to the LS-2010 SX and LS-2010 DX in surgical mode are listed below.
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 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 Quevrat), and Bowenoid Papulosis (BP) lesions; nevi, including spider, epidermal, and protruding; neurofibromas; de-epithelialization; tricoepitheliomas; xanthelasma palpebrarum; syringoma; laser complete or partial nail matrixectomy; benign vascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including; paronychial, periungal, and subungual warts; blepharoplasty; and hair transplantation site preparation.
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
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Image /page/10/Picture/0 description: The image shows the logo for "lightScalpel". The word "light" is in bold font, and the word "Scalpel" is in a lighter font. A curved line starts from the bottom left of the image, goes under the word "light", and then curves over the top of the word "Scalpel".
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; extraction site hemostasis.
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; midiastinal 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.
Gynecology / Genitourinary:
Incision, excision, ablation, and/or vaporization of soft tissue for treatment of: Conization of the cervix, including cervical intraepithelial neoplasia 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; uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectorny.
Otorhinolaryngology / ENT:
Laser incision, excision, ablation, vaporization, and / or photocoagulation of soft tissue in otorhinolaryngology for treatment of: leukoplakia, including oral, larvnx, uyula, palatal, and upper lateral pharyngeal tissue; adult and juvenile papillomatosis polyps; lymphangioma removal; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsillectomy (including tonsilar 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, periungal, 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.
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Image /page/11/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, lowercase letters, and the word "Scalpel" is in regular font, with the "S" stylized as a curved line extending from the "t" in "light" and ending in a starburst shape. The registered trademark symbol is located to the right of the word "Scalpel". A horizontal line is located at the bottom of the image.
Orthopedic Surgery:
Laser incision / excision, ablation, and /or vaporization of soft tissue in orthopedic surgery. Applications include: menisectomy; 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, lopomas, and large tumors); arteriovenous malformation; and pituitary gland tumors (transphenoidal approach).
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Image /page/12/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the word "Scalpel" is in a smaller, non-bold font. A curved line extends from the "S" in "Scalpel" down to a star-like symbol with eight points. The registered trademark symbol is located to the right of the word "Scalpel".
7. Technological Characteristics Comparison to Predicate Devices
The technological characteristics comparison to predicate devices is summarized in the following table.
| Predicate 510(k) | Characteristic | LightScalpel
LS-2010 SX | LightScalpel
LS-2010 FX | LightScalpel
LS-2010 DX | LightScalpel
LS-2010
K141658 | Lutronic
eCO2™
K100610 | Lasering
MiXto
K110984 |
|---------------------------------------------|----------------|---------------------------------|-----------------------------------------|-----------------------------------------|------------------------------------|--------------------------------|---------------------------------|
| Laser Medium | | CO2 | CO2 | CO2 | CO2 | CO2 | CO2 |
| Wavelength (μm) | | 10.6 | 10.6 | 10.6 | 10.6 | 10.6 | 10.6 |
| Laser Drive Source | | RF | RF | RF | RF | RF | DC |
| Energy Delivery - Cont. Wave (CW) | | | | | | | |
| Output Power (W) | | 2-20 | -- | 2-20 | 2-20 | 30 Max | 30 Max |
| Pulsed Power (W) | | 2-20 | -- | 2-20 | 2-20 | -- | 5 - 25 |
| | Single | 5-500 | -- | 5-500 | 5-500 | 10-1000 | 50 - 1000 |
| Gated PW (ms) | Repeat | 5-200 | -- | 5-200 | 5-200 | | |
| Gated Rep. Rate (pps) | | 1 - 50 | -- | 1-50 | 1-50 | 1 - 550 | 1 - 100 |
| Single Pulse Energy (mJ) | | 10-10000 | -- | 10-10000 | 10-10000 | -- | -- |
| Energy Delivery - Superpulse (SP) | | | | | | | |
| Superpulse (W) | | 2-10 | -- | 2-10 | 2-10 | -- | .5 - 12 |
| Superpulse Peak (W) | | 50 | -- | 50 | 50 | -- | -- |
| | Single | 10-500 | -- | 10-500 | 10-500 | 1-1000 | -- |
| Gated PW (ms) | Repeat | 10-200 | -- | 10-200 | 10-200 | -- | -- |
| SP Pulse Rates (pps) | | 150-500 | -- | 150-500 | 150-500 | -- | -- |
| SP Gated Rep Rates (pps) | | 1-50 | -- | 1-50 | 1-50 | -- | -- |
| SP Pulse Width (usec) | | 100-800 | -- | 100-800 | 100-800 | 1000-5000 | -- |
| Energy Delivery - Scanner | | | | | | | |
| Pulse Duration (msec) | | -- | 0.1-6.6 | 0.1-6.6 | -- | 0.10-13.4 | 0.25-16 |
| Pulse Energy (mJoules) | | -- | 10-150 | 10-150 | -- | 2-240 | 1-480 |
| Energy Adjustability | | -- | 10 mJ Inc. | 10 mJ Inc. | -- | -- | -- |
| Pulse Frequency (Hz) | | -- | 75-150 | 75-150 | -- | 10-200 | -- |
| Peak Power (W) | | -- | ~23 | ~23 | -- | 30 | -- |
| Radiation Scan Area (mm) | | -- | 5x5 — 10x10 | 5x5 - 10x10 | -- | 18x18 | Up to 20x20 |
| Scan Shapes | | -- | Image: scan shapes | Image: scan shapes | -- | Image: scan shapes | Image: scan shapes |
| Beam Diameter (Fractional - mm) | | -- | 0.25 | 0.25 | -- | 0.12 | 0.12 / 0.30 |
| Scan Density (%) | (Ablative %) | -- | 5, 8, 14 (100) | 5, 8, 14 (100) | -- | 1 - 14 | 5 - 40 (100) |
| Beam Density (spots/cm2) | | -- | 100 (5%), 144
(8%), 289 (14%) | 100 (5%), 144
(8%), 289 (14%) | -- | 25-400 | -- |
| Inter-beam Spacing (mm) | | -- | 1mm (5%),
0.8mm (8%),
0.6mm (14%) | 1mm (5%),
0.8mm (8%),
0.6mm (14%) | -- | 0.7mm (14%) | -- |
| Visible Laser Indicator | | | | | | | |
| Diode, 635-650nm, ≤ 5mw,
Class IIIa / 3R | | -- | × | × | -- | × | × |
| Physical Specifications | | | | | | | |
| Beam Delivery System | | Flexible Fiber Waveguide | | | Flexible Fiber
Waveguide | Articulated
Arm | Articulated
Arm / WG |
| System HxWxD (in) | | 40x15x15 | | | 40x15x15 | 74x14x18 | 48x15x17 |
| System Weight (Ib) | | | 47 | | 47 | 106 | 88 |
| Mobility | | 4 Wheels & Handle | | | 4 Wheels
& Handle | 4 Wheels
& Handle | 4 Wheels
& Handle |
| Electrical Specifications | | | | | | | |
| Input Voltage, Frequency, Amps | | 100-240VAC
50/60Hz
8A Max | | | 100-240VAC
50/60Hz
8A Max | 100-240VAC
50/60Hz
600VA | 100-240VAC
50/60Hz
4A Max |
| able | |
|---|---|
| ------ | -- |
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Image /page/13/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, lowercase letters, and the word "Scalpel" is in regular font, with a curved line connecting the "t" in "light" to the "S" in "Scalpel". There is a star-like symbol below the word "light".
The LS-2010 Series laser systems are substantially equivalent to the predicate devices in emission wavelength, control parameters, relative output power, delivery accessories, and physical size.
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- Non-clinical performance data: Each LS-2010 Series laser system is tested for electrical safety and output characteristics. Representative data sheets are presented in the Bench Testing section of this report.
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- Clinical performance data: None. Clinical testing was determined to be unnecessary, as the performance parameters are consistent with predicate CO2 laser systems and technology.
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- In summary, the LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX CO₂ laser systems are equivalent to the predicate laser systems for the indicated uses in the stated medical specialties.