(63 days)
Not Found
Not Found
No
The 510(k) summary describes a CO2 laser system for various soft tissue procedures. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the presence of AI/ML. The description focuses on the laser's capabilities for ablation, vaporization, excision, and coagulation.
Yes
The device is indicated for a wide range of medical treatments including "ablation, vaporization, excision, or coagulation of soft tissue" for various conditions and procedures across multiple medical specialties, which are therapeutic applications.
No
This device is indicated for surgical and aesthetic applications requiring ablation, vaporization, excision, or coagulation of soft tissue, primarily for treatment purposes, not for diagnosing conditions.
No
The device is a CO2 laser system, which is a hardware-based medical device used for surgical and aesthetic applications involving soft tissue. The description focuses on the physical actions of the laser (ablation, vaporization, excision, coagulation) and the types of delivery devices and accessories, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside the body (in vitro).
- Device Function: The description clearly states the device is a CO2 Laser System used for surgical and aesthetic applications involving the direct ablation, vaporization, excision, or coagulation of soft tissue on or within the body.
- Intended Use: The intended uses listed are all procedures performed directly on the patient's body for treatment or removal of tissue, not for analyzing samples taken from the body.
Therefore, the Modified ULTRApulse Alpha CO2 Laser System is a surgical/therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring:
ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including; dermatology and plastic surgery (aesthetic), podiatry, gyneoology, general and thoracic surgery, dental and oral surgery and genitourinary surgery as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
-
· Laser skin resurfacing
-
· Laser derm-abrasion
-
· Laser burn debridement
-
-Laser skin resurfacing (ablation and/or vaporization) for treatment of:
-
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
-
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
-
· Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca 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 telangiectaticum)
-
Tattoos
-
· Telangiectasia
-
· Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
-
· Superficial pigmented lesions
-
Adenosebaceous hypertrophy or sebaceous hyperplasia
-
· Rhinophyma reduction
-
· Cutaneous papilloma (skin tags)
-
Milia
-
Debridement of eczematous or infected skin
-
· Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
-
· Nevi, including spider, epidermal and protruding
-
· Neurofibromas
-
· Laser de-epithelialization
-
· Tricoepitheliomas
-
· Xanthelasma palpebrarum
-
· Syringoma
-Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy. -
Vaporization or coagulation of:
-
· Benign and malignant vascular/avascular skin lesions
-
· Moh's Surgery
-
Lipectomy
-
· Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts
-Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
-Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
- Porokeratoma ablation
- · Ingrown nail treatment
- Neuromas/fibromas, including Morton's neuroma
- Debridement of ulcers
- Other soft tissue lesions
Laser ablation, vaporization, and/or excision for complete and partial matrixectomy
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
- · vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
- · Condyloma acuminata, including genital, vulvar, perineal, and Bowen's disease (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions
- · Leukoplakia (vulvar dystrophies)
- · Incision and drainage (I&D) of Bartholin's and nubuthian cysts
- · Herpes vaporization
- Urethral caruncle vaporization
- Benign and malignant tumors
- · Hemangiomas
General Surgery
- Debridement of traumatic wounds
- Debridement of decubitus and diabetic ulcers
- · Microsurgery
- · Artificial joint revision
- PMMA removal
General and Thoracic Surgery
Incision, excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- · 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 applications
- · Mediastinal and thoracic lesions and abnormalities
- Skin tag vaporization
- Atheroma
- · Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
- · Pilonidal cyst removal and repair
- Abscesses
- · Other soft tissue applications
Dental and Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- · Gingivectomy/removal of hyperplasias
- · Gingivoplasty
- · Incisional and excisional biopsy
- · Treatment of ulcerous lesions, including aphthous ulcers
- · Incision of infection when used with antibiotic therapy
- · Frenectomy (frenum release)
- · Excision and ablation of benign and malignant lesions
- · Homeostasis
- · Operculectomy
- · Crown lengthening
- · Removal of soft tissue, cysts and tumors
- Oral cavity tumors and hemangiomas
- Abscesses
- · Extraction site hemostasis
- Salivary gland pathologies
- · Preprosthetic gum preparation
- Leukoplakia
- · Partial glossectomy
- Periodontal gum resection
Genitourinary
Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:
- · Benign and malignant lesions of external genitalia
- Condyloma
- Phimosis
- · Erythroplasia
The Lumenis Be modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, gynecology, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, eyelid, nail, vulvar, vaginal, urethral, rectum, anal, breast, oral cavity, salivary gland, teeth, external genitalia.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2023
Lumenis Be Ltd. Shlomit Segman Sr. Director RA Hakidma Street 9, P.O.B. 426 Yokneam Industrial Park, 2069236 Israel
Re: K233301
Trade/Device Name: ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories 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: September 29, 2023 Received: September 29, 2023
Dear Shlomit Segman:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
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 (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Tanisha L. Hithe -2023.12.01 Hithe -S 14:41:43 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
51 O(k) Number (if known)
Device Name
The Modified ULTRApulse Alpha CO2 Surgical and Aesthetic Laser, Delivery Devices and Accessories
Indications for Use (Describe)
The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring:
ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including; dermatology and plastic surgery (aesthetic), podiatry, gyneoology, general and thoracic surgery, dental and oral surgery and genitourinary surgery as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- · Laser skin resurfacing
- · Laser derm-abrasion
- · Laser burn debridement
- -Laser skin resurfacing (ablation and/or vaporization) for treatment of:
- · Wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
- -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- · Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca 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 telangiectaticum)
- Tattoos
- · Telangiectasia
- · Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
- · Superficial pigmented lesions
- Adenosebaceous hypertrophy or sebaceous hyperplasia
- · Rhinophyma reduction
- · Cutaneous papilloma (skin tags)
- Milia
- Debridement of eczematous or infected skin
- · Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
- · Nevi, including spider, epidermal and protruding
- · Neurofibromas
- · Laser de-epithelialization
- · Tricoepitheliomas
- · Xanthelasma palpebrarum
4
· Syringoma
-Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy.
-
Vaporization or coagulation of:
-
· Benign and malignant vascular/avascular skin lesions
-
· Moh's Surgery
-
Lipectomy
-
· Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts
-Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
-Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
Podiatry
Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts
- Porokeratoma ablation
- · Ingrown nail treatment
- Neuromas/fibromas, including Morton's neuroma
- Debridement of ulcers
- Other soft tissue lesions
Laser ablation, vaporization, and/or excision for complete and partial matrixectomy
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
- · vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
- · Condyloma acuminata, including genital, vulvar, perineal, and Bowen's disease (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions
- · Leukoplakia (vulvar dystrophies)
- · Incision and drainage (I&D) of Bartholin's and nubuthian cysts
- · Herpes vaporization
- Urethral caruncle vaporization
- Benign and malignant tumors
- · Hemangiomas
General Surgery
- Debridement of traumatic wounds
- Debridement of decubitus and diabetic ulcers
- · Microsurgery
- · Artificial joint revision
- PMMA removal
General and Thoracic Surgery
Incision, excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- · 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 applications
- · Mediastinal and thoracic lesions and abnormalities
- Skin tag vaporization
- Atheroma
- · Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
5
- · Pilonidal cyst removal and repair
- Abscesses
- · Other soft tissue applications
Dental and Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- · Gingivectomy/removal of hyperplasias
- · Gingivoplasty
- · Incisional and excisional biopsy
- · Treatment of ulcerous lesions, including aphthous ulcers
- · Incision of infection when used with antibiotic therapy
- · Frenectomy (frenum release)
- · Excision and ablation of benign and malignant lesions
- · Homeostasis
- · Operculectomy
- · Crown lengthening
- · Removal of soft tissue, cysts and tumors
- Oral cavity tumors and hemangiomas
- Abscesses
- · Extraction site hemostasis
- Salivary gland pathologies
- · Preprosthetic gum preparation
- Leukoplakia
- · Partial glossectomy
- Periodontal gum resection
Genitourinary
Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:
- · Benign and malignant lesions of external genitalia
- Condyloma
- Phimosis
- · Erythroplasia
The Lumenis Be modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, gynecology, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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