(124 days)
Not Found
No
The description focuses on the hardware (laser tube, waveguide, handpiece) and basic software control via a touchscreen. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration.
Yes
The device is used for surgical procedures such as incision, excision, vaporization, ablation, and/or coagulation of soft tissue, which are interventions intended to treat a condition.
No
The device description and intended use clearly state that it is a surgical laser system used for incision, excision, vaporization, ablation, and coagulation of soft tissue, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a laser system with hardware components like a laser tube, fiber waveguide, and handpiece assembly, in addition to controlling software.
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 device is used for "laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue". This describes a surgical tool used directly on a patient's body.
- Device Description: The description details a laser system that delivers energy to tissue via a handpiece. This is consistent with a surgical device, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are designed to perform tests on samples taken from the body to diagnose diseases or conditions.
Therefore, the LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are 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, neurosurgery, podiatry, and urology.
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 and malignant tumors; hemangiomas; benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.
Dermatology / Plastic Surgery:
Incision, Excision, Ablation, and Vaporization of soft tissue for treatment of: laser skin resurfacing; laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; keratosis, including actinic and sebortheic keratosis, seborthoecae vulgares, seborthoica; vermillionectomy of the lip; cutaneous horns; solar/actinic elastosis; cheilitis, including actinic cheilitis; lentigines, including lentigo maligna or Hutchinson's malignant freckle; uneven pigmentation/dyschromia; acne scars; 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 fibromas; superficial pigmented lesions baceous 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-epitheliomas; xanthelasma palpebrarum; syringoma; complete or partial nail matrixectomy; benign/malignant vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborthoecae vulgares, including; paronychial, periungal, and subungual warts; blepharoplasty: and hair transplantation site preparation.
Dental Surgery:
Gingivectorny - Removal of hyperplasias; gingivoplasty; papillectomy; vestibuloplasty; epulis; sulcular debridement; removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); extraction site hemont of ulcerous lesions, including aphthous ulcers; a heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament to the root surface in the absence of long junctional epithelium).
Oral Surgery:
Frenum release/frenectomy; abscess (drainage); biopsy (incisional & excisional); aphthous ulcers (incision & excision); excision & ablation of lesions, benign & malignant 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; 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: 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.
Gyn Laparoscopic Surgery:
Laser incision, excision, vaporization 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 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 tonsilar cryptolysis and neoplasma) and tonsil ablation / tonsillotomy; benign and malignant 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 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: porokeratornas/fibromas, including Morton's neuroma removal; ingrown toenail treatment; debridement of ulcers; treatment of other soft tissue lesions.
Orthopedic Surgery:
Laser incision / excision, 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 and malignant 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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LightScalpel LS-1005 / LS-2010 laser systems are mobile platforms that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 and 2 to 20 Watts Continuous Wave (CW) respectively. The systems differ only in the laser tube used, pre-programmed values in the controlling software, which allow higher laser tube drive for the LS-2010 system, and physical height and weight. 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. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control 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:
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: Flexible Fiber Waveguide: ~ 0.75mm ID:: Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips.
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, vagina, vulva, perineum, external genitalia, lips, skin, nails, gum, oral cavity, tongue, salivary gland, mediastinal, thoracic, breast, rectum, anus, endometrium, adhesions, fallopian tube, ovary, uterus, ligaments, ear, larynx, uvula, palate, pharynx, trachea, vocal cords, tonsils, septum, menisci, cartilage, ligaments, joint capsule (synovium), traumatic wounds, decubitus ulcers, diabetic ulcers, and deep tissue for PMMA removal, posterior fossa, peripheral nerves, pituitary gland.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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-1005 and LS-2010 laser system is tested for electrical safety and output characteristics. Representative data is 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K123037, K132661, K103501, K100415, K971743
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three faces in profile, representing the department's focus on health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2014
LightScalpel® LLC Mr. David Walters General Manager 16932 Woodinville-Redmond Road Northeast, Suite 107 Woodinville, Washington 98072
Re: K141658
Trade/Device Name: LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems 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 26, 2014 Received: August 28, 2014
Dear Mr. 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. 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K141658
Device Name
LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems
Indications for Use (Describe)
Indications for Use:
The LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are 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, neurosurgery, podiatry, and urology.
Gynecology / Genitourinary:
Incision, excision, ablation, and/or vaporization of soft tissue for treatment of: Conization of the cervix, including cervical intraepithelial neoplasia and varinal 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 and malignant tumors; hemangiomas; benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Number (if known) K141658
Device Name
LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems
Indications for Use (Describe)
Dermatology / Plastic Surgery:
Incision, Excision, Ablation, and Vaporization of soft tissue for treatment of: laser skin resurfacing; laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; keratosis, including actinic and sebortheic keratosis, seborthoecae vulgares, sebortheica; vermillionectomy of the lip; cutaneous horns; solar/actinic elastosis; cheilitis, including actinic cheilitis; lentigines, including lentigo maligna or Hutchinson's malignant freckle; uneven pigmentation/dyschromia; acne scars; 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 fibromas; superficial pigmented lesions baceous 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-epitheliomas; xanthelasma palpebrarum; syringoma; complete or partial nairixectomy; benign/malignant vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborthoecae vulgares, including; paronychial, periungal, and subungual warts; blepharoplasty: and hair transplantation site preparation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
VOL_005 Page 2 of 6
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
510(k) Number (if known) K141658
Device Name
LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems
Indications for Use (Describe)
Dental Surgery:
Gingivectorny - Removal of hyperplasias; gingivoplasty; papillectorny; vestibuloplasty; epulis; sulcular debridement; removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); extraction site hemont of ulcerous lesions, including aphthous ulcers; a heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament to the root surface in the absence of long junctional epithelium).
Oral Surgery:
Frenum release/frenectomy; abscess (drainage); biopsy (incisional & excisional); aphthous ulcers (incision & excision); excision & ablation of lesions, benign & malignant 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; extraction site hemostasis.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
510(k) Number (if known) K141658
Device Name
LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems
Indications for Use (Describe)
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.
Gyn Laparoscopic Surgery:
Laser incision, excision, vaporization 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
510(k) Number (if known) K141658
Device Name
LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems
Indications for Use (Describe)
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 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; tonsiller tonsillar cryptolysis and neoplasma) and tonsil ablation / tonsillotomy; benign and malignant 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 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: porokeratornas/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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
510(k) Number (if known) K141658
Device Name
LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems
Indications for Use (Describe)
Orthopedic Surgery:
Laser incision / excision, 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 neurectorny; benign and malignant 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
8
Image /page/8/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the "S" in "Scalpel" is stylized as a curved line that extends below the word and ends in a star-like burst. The rest of the word "Scalpel" is in a regular font. There is a registered trademark symbol next to the word "Scalpel".
VOL_006 - 510(k) Summary
510(k) Summary Preparation Date: 17 June 2014
-
- 510(K) Owner:
LightScalpel® LLC 16932 Woodinville-Redmond Road NE, Suite 107 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-368-1568 (FAX)
- 510(K) Owner:
-
- 510(k) Contact:
David Walters General Manager 16932 Woodinville-Redmond Road NE, Suite 107 Woodinville, WA 98072 866-697-7548 / 425-368-1588 / 425-368-1568 (FAX) dwalters@lightscalpel.com
- 510(k) Contact:
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- Device Trade Name: LightScalpel® LS-1005 / LS-2010
Common Name: CO2 Laser System
- Device Trade Name: LightScalpel® LS-1005 / LS-2010
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/9/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 above the "S" in "Scalpel", goes over the word, and ends in a starburst below the word "light".
5. Device Description and Function
The LightScalpel LS-1005 / LS-2010 laser systems are mobile platforms that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 and 2 to 20 Watts Continuous Wave (CW) respectively. The systems differ only in the laser tube used, pre-programmed values in the controlling software, which allow higher laser tube drive for the LS-2010 system, and physical height and weight. 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. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control 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 wavequide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below:
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: Flexible Fiber Wavequide: ~ 0.75mm ID:: Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips.
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/10/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the word "Scalpel" is in a normal font. A curved line starts from the top of the "S" in "Scalpel" and extends down to the bottom left of the logo, where it ends in a star-like shape.
6. Intended use(s) of the Device
The LightScalpel 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.
A listing of typical laser surgery procedures in the medical specialties follows:
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 and malignant tumors; hemangiomas;; benign and malignant lesions of external genitalia; condyloma; phimosis; erythoplasia.
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; 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 malignant freckle; uneven pigmentation/dyschromia; acne scars; surgical scars; keloids, including acne keloidalis nuchae; hemangiomas, including Buccal, port wine, and pyogenic granuloma, pyogenicum/granuloma telagiectatioum; tatoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subunqual fibromas: superficial 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 deepitheliazation; tricoepitheliomas; xanthelasma palpebrarum; syringoma; complete or partial nail matrixectomy; benign/malignant 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, tonque); 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).
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Image /page/11/Picture/0 description: The image shows the logo for LightScalpel. The word "light" is in bold, lowercase letters, and the word "Scalpel" is in lowercase letters. A curved line extends from the top of the "S" in "Scalpel" and ends in a starburst shape at the bottom left of the logo. The registered trademark symbol is located to the right of the word "Scalpel".
Oral Surgery:
Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional & excisional); aphthous ulcers (incision & excision & ablation of lesions, benign & malignant 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.
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; hysterectorny.
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, larvnx, 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 and malignant 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 glossectorny; 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/12/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, lowercase letters. The word "Scalpel" is in regular font, with the "S" stylized as a curved line that extends below the word and ends in a starburst shape. The trademark symbol is located to the right of the word "Scalpel".
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 and malignant 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/13/Picture/0 description: The image shows the logo for "lightScalpel". The word "light" is in bold, and the word "Scalpel" is in a regular font. A curved line starts below the word "light" and extends over the word "Scalpel". At the end of the curved line, there is a star-like symbol.
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- Technological Characteristics Comparison to Predicate Devices
The technological characteristics comparison to predicate devices is summarized in the following table.
- Technological Characteristics Comparison to Predicate Devices
| | LS-1005 /
LS-2010
K141658 | LS-1005
K123037
K132661 | Alma
Pixel CO2™
K103501 | Lumenis
AcuPulse™
K100415 | Sharplan
15F
K971743 |
|-----------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Characteristic | -- | -- | -- | -- | -- |
| Laser Medium | CO2 | CO2 | CO2 | CO2 | CO2 |
| Wavelength (um) | 10.6 | 10.6 | 10.6 | 10.6 | 10.6 |
| Laser Drive Source | RF | RF | RF | DC | DC |
| Output Power (W) | 2-10 / 2-20 | 2-10 | 70 | 1 - 30 | 1 - 15 |
| Pulsed Power (W) | 2-10 / 2-20 | 2-10 | -- | 1 - 25 | N/A |
| Gated PW (ms) | 5-500 | 5-500 | 10 - 1000 | 50 - 1000 | 100 - 1000 |
| Gated Rep. Rate (pps) | 1 or 2-20 | 1 or 2-20 | 1 - 100 | 1 - 100 | Adj - On/Off |
| Superpulse (W) | 2-5 / 2-10 | 2-5 | -- | .5 - 10 | N/A |
| Superpulse Peak (W) | 30 / 60 | 30 | -- | N/A | N/A |
| Beam Delivery System | Flexible Fiber
Waveguide | Flexible Fiber
Waveguide | Articulated Arm | Articulated Arm
or WG | Articulated
Arm/WG |
| System HxWxD (in) | 34x15x15 /
40x15x15 | 34x15x15 /
40x15x15 | 52x17x21 | 47x15x16 | 4.3x9.4x28.3 |
| System Weight (Ib) | 35 / 47 | 35 / 47 | 135 | 108 | 33 |
| Mobility | 4 Wheels &
Handle | 4 Wheels &
Handle | 4 Wheels &
Handle | 4 Wheels &
Handle | 4 Wheels &
Handle |
| Intended Use | Incision, Excision,
Vaporization,
Ablation, and/or
Coagulation of
Soft Tissue | Incision, Excision,
Vaporization,
Ablation, and/or
Coagulation of
Soft Tissue | Incision, Excision,
Vaporization,
Ablation, and/or
Coagulation of
Soft Tissue | Incision, Excision,
Vaporization,
Ablation, and/or
Coagulation of
Soft Tissue | Incision
Excision
Vaporization
Ablation
And/or
Coagulation of
Soft Tissue |
| Line Voltage - Nom. | 100-240 VAC | 100-240 VAC | 120/230 VAC | 100-240 VAC | 100-140 VAC |
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Image /page/14/Picture/0 description: The image shows the logo for "light Scalpel". The word "light" is in bold, and the "S" in "Scalpel" is stylized with a curved line extending from the top of the "S" over the word "light". There is a star-like symbol below the word "light". The registered trademark symbol is next to the word "Scalpel".
The LS-1005 and LS-2010 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-1005 and LS-2010 laser system is tested for electrical safety and output characteristics. Representative data is 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.
- 10.In summary, the LightScalpel LS-1005 and LS-2010 CO2 laser systems are equivalent to the predicate laser systems in technical characteristics and for the intended uses in the stated medical specialties.