(46 days)
Not Found
No
The document describes a laser system for surgical applications and does not mention any AI or ML capabilities. The focus is on the physical components and intended uses of the laser.
Yes
The device is intended for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue across various medical specialties, which are therapeutic actions to address medical conditions.
No.
The device is a laser system intended for surgical applications that ablate, vaporize, excise, incise, and coagulate soft tissue. Its described functions are all therapeutic, not diagnostic.
No
The device description clearly states it is a "Laser System" consisting of multiple hardware components like a console, articulated arm, footswitch, and handpieces, in addition to system software. This is not a software-only device.
Based on the provided text, the Alma Lasers Pixel CO2™ Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The Alma Lasers Pixel CO2™ Laser System is intended for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in vivo (within the living body).
- Lack of Specimen Analysis: The description and intended use clearly indicate that this device directly interacts with and modifies soft tissue within the patient's body. There is no mention of analyzing specimens taken from the body.
Therefore, the Alma Lasers Pixel CO2™ Laser System is a surgical laser system, not an IVD.
N/A
Intended Use / Indications for Use
The Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).
The Alma Lasers Pixel CO2™ Laser System is cleared for the particular indications 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 the treatment of:
- wrinkles, rhytids, and furrows (including fines lines and texture irregularities) .
Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.
Dermatology & Plastic Surgery, continued
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic . wart, and verruca seborrheica;
- . vermillionectomy of the lip;
- cutaneous horns; .
- . solar/actinic elastosis;
- chelitis, including actinic chelitis; .
- 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 granulomas/granuloma . pyogenicum/granuloma telagiectaticum);
- 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;
Dermatology & Plastic Surgery, continued
- nevi, including spider, epidermal and protruding; .
- . neurofibromas;
- laser de-epithelialization; .
- tricoepitheliomas; .
- xanthelasma palpebrarum; .
- syringoma .
Laser ablation, vaporization and /or excision for complete or partial nail matrixectorny.
Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions;
- . Moh's Surgery;
- . Lipectomy;
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungaual ● 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 for excision of soft tissue for the reduction, removal, and/or treatment of:
- verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
- fungal nail treatment; .
- porokeratoma ablation:
- ingrown nail treatment; .
- . neuromas/fibromas, including Morton's neuroma;
- debridement of ulcers; .
- . other soft tissue lesions.
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- choanal atresia,
- leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue;-.
- . nasal obstruction;
- . adult and juvenile papillomatosis polyps;
- . polypectomy of nose and nasal passages;
- . lymphangioma removal:
- removal of vocal cord/fold nodules, polyps and cysts: .
- . 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:
Otolaryngology (ENT), continued
- lascr/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; .
- Zenker's Diverticulum/pharyngoesophageal divertuculostomy [endoscopic laser-assisted . esophagodivertuculostomy (ELAED)];
- stenosis, including subglottic stenosis;
- tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
- . pulmonary bronchial and tracheal lesion removal;
- benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, . tracheobronchial/endobronchial);
- . benign and malignant lesions and fibromas (nose and nasal passages);
- . benign and malignant tumors and fibromas; (oral);
- . stapedotomy/stapedectomy;
- acoustic neuroma in the ear; .
- . superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease;
- . telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
- . cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
- . myringotomy/tympanostomy (tympanic membrane fenestration);
- . uvulopalatoplasty (LAUP, laser UPPP);
- . turbinectomy and turbinate reduction/ablation);
- . septal spur ablation/reduction and septoplasty:
- partial glossectomy: .
- tumor resection on oral, subfacial and neck tissues; .
- . rhinophyma;
- verrucae vulgares (warts); .
- gingivoplasty/gingivoctomy.
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
- conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and . vaginal intraepithelial neoplasia (VIN, VAIN);
- condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, . (Erythroplasia 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;
- cervical dysplasia; ●
- . benign and malignant tumors;
- hemangiomas. ◆
GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
- . endometrial lesions, including ablation of endometriosis;
- . excision/lysis of adhesions;
- . salpingostomy;
- . oophorectomy/ovariectomy;
- . fimbroplasty;
- . metroplasty;
- . microsurgery (tubal);
- uterine myomas and fibroids; .
GYN Laparoscopy, continued
- . ovarian fibromas and follicle cysts;
- . uterosacral ligament ablation;
- . hysterectomy.
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
- . posterior fossa tumors;
- peripheral neurectomy;
- benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal e tumors), acoustic neuromas, lipomas and large tumors);
- . arteriovenous malformation;
- . pituitary gland tumors (transphenoidal approach).
Spinal Cord
- incision/excision and vaporization of benign and malignant tumors and cysts:
- intra- and extradural lesions;
- laminectomy/ laminotomy/ microdiscectomy. ●
Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy
- . menisectomy;
- . chodromalacia;
- chondroplasty;
- ligament release (lateral and other);
- . excision of plica;
- partial synovectomy.
General
- deridement of traumatic wounds;
- debridement of decubitus and diabetic ulcers; ●
- microsurgery;
- artificial joint revision; ●
- PMMA removal.
General/Thoracic Surgery
Incision, excision and vaporization and 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; ●
General/Thoracic Surgery, continued
- reduction mammoplasty; .
- cytoreduction for metastatic disease; .
- laparotomy and laparoscopic 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/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;
Dental/Oral Surgery, continued
- o 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 and of soft tissue in genitourinary procedures. Applications include:
- . benign and malignant lesions of external genitalia;
- . condyloma;
- . phimosis
- erythroplasia. .
The Alma Lasers Pixel CO2TM Laser System, Delivery Device and Accessories are used to deliver light energy and are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties, including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee) , general and thoracic surgery (including open and endoscopic), oral surgery and genitourinary surgery.
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
The Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories are used to deliver light energy and are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties, including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee) , general and thoracic surgery (including open and endoscopic), oral surgery and genitourinary surgery.
The Alma Lasers Pixel CO2™ CO2 Laser System consists of the following major components (refer to Error! Reference source not found.):
- Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
- LCD control panel with touch-screen technology
- 7-joint articulated arm
- Footswitch
- Delivery Device Handpieces:
- . Focusing handpieces
- Pixel handpieces .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, lip, nail matrix, skin lesions, eyelid, hair recipient sites, verrucae vulgares/plantar (warts), fungal nail, porokeratoma, ingrown nail, neuromas/fibromas, ulcers, choanal atresia, leukoplakia (oral, larynx, uvula, palatal, upper lateral pharyngeal tissue), nasal passages, vocal cord/fold, oral cavity, nasal cavity, trachea, tongue, larynx, pharynx, nasal, ear, Zenker's Diverticulum/pharyngoesophageal diverticulum, subglottic, tonsils, pulmonary bronchial, tracheobronchial/endobronchial, ear, tympanic membrane, uvula, palatal, turbinate, septum, glossectomy, subfacial, neck, gingiva, cervix, vulva, vagina, perineum, Bartholin's and nubuthian cysts, urethra, endometrium, adhesions, fallopian tube, ovary, uterus, uterine myomas, fibroids, uterosacral ligament, brain (posterior fossa, pituitary gland), peripheral nerve, spinal cord, meningiomas, lipomas, arteriovenous malformation, menisci, chondromalacia, ligaments, plica, synovium, traumatic wounds, decubitus ulcers, diabetic ulcers, artificial joint, breast, rectum, anus, mediastinal, thoracic, sebaceous cysts, pilar cysts, mucous cysts of the lips, pilonidal cyst, abscesses, oral cavity, salivary gland, gum, 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): 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.
Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories (K080463)
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 Department of Health & Human Services USA. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alma Lasers, Inc. % Ms. Tatiana Epstein Vice President, QA and RA 485 Half Day Road, Suite 100 Buffalo Grove, Illinois 60089
Re: K103501
Trade/Device Name: Alma Lasers Pixel CO2" Laser System, Delivery Devices and Accessories Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: January 04, 2011 Received: January 07, 2011
Dear Ms. Epstein:
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. Iisting 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.
JAN 1 4 2011
1
Page 2 - Ms. Tatiana Epstein
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Aty B. 12 h
fr.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
2
K10 3 50 | 510(k) Number (if known):
Alma Lasers Pixel CO2TM Laser System, Delivery Devices and Accessories Device Name:
Indications for Use:
The Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).
The Alma Lasers Pixel CO2™ Laser System is cleared for the particular indications 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 the treatment of:
- wrinkles, rhytids, and furrows (including fines lines and texture irregularities) .
Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ilapdsall for min
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103501
3
3
510(k) Number (if known): K10 350 |
Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories Device Name:
Indications for Use - Continued from the previous page:
Dermatology & Plastic Surgery, continued
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic . wart, and verruca seborrheica;
- . vermillionectomy of the lip;
- cutaneous horns; .
- . solar/actinic elastosis;
- chelitis, including actinic chelitis; .
- 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 granulomas/granuloma . pyogenicum/granuloma telagiectaticum);
- 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;
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil RP. Sylvan fix
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K103501
Page 2 of 10
$\gamma$
4
510(k) Number (if known): K10 350 /
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Dermatology & Plastic Surgery, continued
- nevi, including spider, epidermal and protruding; .
- . neurofibromas;
- laser de-epithelialization; .
- tricoepitheliomas; .
- xanthelasma palpebrarum; .
- syringoma .
Laser ablation, vaporization and /or excision for complete or partial nail matrixectorny.
Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions;
- . Moh's Surgery;
- . Lipectomy;
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungaual ● 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nat Al. Dail
Division Sign 06
fix. mxa
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K10.35
Page 3 of 10
ડ
5
510(k) Number (if known): K10 3501
Alma Lasers Pixel CO2TM Laser System, Delivery Devices and Accessories Device Name:
Indications for Use - Continued from the previous page:
Podiatry
Laser ablation, vaporization and for excision of soft tissue for the reduction, removal, and/or treatment of:
- verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
- fungal nail treatment; .
- porokeratoma ablation: �
- ingrown nail treatment; .
- . neuromas/fibromas, including Morton's neuroma;
- debridement of ulcers; .
- . other soft tissue lesions.
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- choanal atresia,
- leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue;-.
- . nasal obstruction;
- . adult and juvenile papillomatosis polyps;
- . polypectomy of nose and nasal passages;
- . lymphangioma removal:
- removal of vocal cord/fold nodules, polyps and cysts: .
- . 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:
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N.L.B. de A.L. S.
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page 4 of 10
6
6
510(k) Number (if known): K10 350)
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Otolaryngology (ENT), continued
- lascr/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; .
- Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted . esophagodivertuculostomy (ELAED)];
- stenosis, including subglottic stenosis;
- tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
- . pulmonary bronchial and tracheal lesion removal;
- benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, . tracheobronchial/endobronchial);
- . benign and malignant lesions and fibromas (nose and nasal passages);
- . benign and malignant tumors and fibromas; (oral);
- . stapedotomy/stapedectomy;
- acoustic neuroma in the ear; .
- . superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease;
- . telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
- . cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
- . myringotomy/tympanostomy (tympanic membrane fenestration);
- . uvulopalatoplasty (LAUP, laser UPPP);
- . turbinectomy and turbinate reduction/ablation);
- . septal spur ablation/reduction and septoplasty:
- partial glossectomy: .
- tumor resection on oral, subfacial and neck tissues; .
- . rhinophyma;
- verrucae vulgares (warts); .
- gingivoplasty/gingivoctomy.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
currence of CDRH, Office of Device Evaluation (ODE)
Neil K. Regle for m
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K103501
5 Page of 10
7
K10 3501 510(k) Number (if known):
Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories Device Name:
Indications for Use - Continued from the previous page:
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
- conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and . vaginal intraepithelial neoplasia (VIN, VAIN);
- condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, . (Erythroplasia 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;
- cervical dysplasia; ●
- . benign and malignant tumors;
- hemangiomas. ◆
GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
- . endometrial lesions, including ablation of endometriosis;
- . excision/lysis of adhesions;
- . salpingostomy;
- . oophorectomy/ovariectomy;
- . fimbroplasty;
- . metroplasty;
- . microsurgery (tubal);
- uterine myomas and fibroids; .
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nxt R.P. Dal fir mkn
(Division Sigh-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K10-3501
Page 6 of 10
-157
8
510(k) Number (if known): K10 3501
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
GYN Laparoscopy, continued
- . ovarian fibromas and follicle cysts;
- . uterosacral ligament ablation;
- . hysterectomy.
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
- . posterior fossa tumors;
- peripheral neurectomy;
- benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal e tumors), acoustic neuromas, lipomas and large tumors);
- . arteriovenous malformation;
- . pituitary gland tumors (transphenoidal approach).
Spinal Cord
- incision/excision and vaporization of benign and malignant tumors and cysts:
- intra- and extradural lesions;
- laminectomy/ laminotomy/ microdiscectomy. ●
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N.S.P.R.B.L. for asks
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103501
Page 7 of 10
ਹਵਿਲ
9
9
510(k) Number (if known): K10 350 1
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy
- . menisectomy;
- . chodromalacia;
- � chondroplasty;
- ligament release (lateral and other); .
- . excision of plica;
- partial synovectomy.
General
- deridement of traumatic wounds;
- debridement of decubitus and diabetic ulcers; ●
- microsurgery;
- artificial joint revision; ●
- PMMA removal.
General/Thoracic Surgery
Incision, excision and vaporization and 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; ●
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K10-350 |
|---|---|
| --------------- | --------- |
Page 8 of 10ਜ ਦਿਰ
10
K10 350 | 20 510(k) Number (if known):
Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories Device Name:
Indications for Use - Continued from the previous page:
General/Thoracic Surgery, continued
- reduction mammoplasty; .
- cytoreduction for metastatic disease; .
- laparotomy and laparoscopic 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/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;
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K103501 |
|---|---|
| Page 9 of 10 | |
| 160 |
11
510(k) Number (if known): K10 3501
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Dental/Oral Surgery, continued
- o 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 and of soft tissue in genitourinary procedures. Applications include:
- . benign and malignant lesions of external genitalia;
- . condyloma;
- . phimosis
- erythroplasia. .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Net. R.P. Side for mka
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number. K103501.
Page 10 of 10
484
12
Appendix 7-510(k) Summary for the Alma Lasers Pixel CO2TM Laser System, Delivery Devices and Accessories
Summary Preparation Date: November 24, 2010
· General Information
| Sponsor/
510(k) Owner
Address and
Establishment
| Registration # | Sponsor | ||
|---|---|---|---|
| Alma Lasers, Inc. | |||
| 485 Half Day Rd. Suite No. 100 | |||
| Buffalo Grove, IL 60089, USA | |||
| FDA Registration #: 3004167969 | |||
| Tatiana Epstein | |||
| VP QA&RA | |||
| Alma Lasers, Inc. | Telephone: | ||
| Facsimile: | |||
| Email: | (224) 377-2011 | ||
| (224) 377-2050 | |||
| tatianae@almalasers.com | |||
| Contact Person: | Main Contact: | ||
| Tatiana Epstein | |||
| VP QA&RA | |||
| Alma Lasers, Inc. | Telephone: | ||
| Facsimile: | |||
| Email: | (224) 377-2011 | ||
| (224) 377-2050 | |||
| tatianae@almalasers.com | |||
| Secondary Contact: | |||
| Avi Farbstein | |||
| EVP and GM North America | Telephone: | ||
| Facsimile: | (224) 377-2011 | ||
| (224) 377-2050 |
· Names
Alma Lasers Pixel CO2TM Laser System, Delivery Device Names: Devices and Accessories
Primary Classification Names: Laser Instrument, Surgical, Powered; GEX
· Predicate Devices
Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories (K080463), cleared 07/23/2008
• Product Description
The Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories are used to deliver light energy and are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties, including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee) , general and thoracic surgery (including open and endoscopic), oral surgery and genitourinary surgery.
The Alma Lasers Pixel CO2™ CO2 Laser System consists of the following major components (refer to Error! Reference source not found.):
-
- Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
13
-
- LCD control panel with touch-screen technology
-
- 7-joint articulated arm
- Footswitch 9.
-
- Delivery Device Handpieces:
- . Focusing handpieces
- Pixel handpieces .
· Indications for Use
The Alma Lasers Pixel CO2TM Laser System, Delivery Device and Accessories are used to deliver light energy and are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties, including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee) , general and thoracic surgery (including open and endoscopic), oral surgery and genitourinary surgery.
The intended use is identical to that previously cleared for the Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories (K080463).
The Indications for Use statement can be found in Appendix 4.
· Rationale for Substantial Equivalence
The Alma Lasers Pixel CO2TM Laser System, Delivery Device and Accessories has the following similarities to the previously cleared Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories (K080463):
- Has the same intended use and indications for use, .
- . Uses the same operating principle (technology),
- . Incorporates the same basic design,
- Incorporates the same materials, .
- Is packaged using the same materials and processes. .
In summary, the Alma Lasers Pixel CO2™ Laser System, Delivery Device and Accessories is substantially equivalent to the predicate devices.
· Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Pixel CO2M Laser System, Delivery Device and Accessories is substantially equivalent to the predicate device.
· Conclusion
Alma Lasers Pixel CO2™ Laser System, Delivery Device and Accessories was found to be substantially equivalent to the predicate Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories (K080463).
14
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2TM Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Dermatology & Plastic Surgery, continued
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- . keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica;
- . vermillionectomy of the lip;
- cutaneous horns; .
- solar/actinic elastosis; .
- . chelitis, including actinic chelitis;
- 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 granulomas/granuloma pyogenicum/granuloma telagiectaticum);
- 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;
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 10
ਜਵੰਤੇ
15
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Dermatology & Plastic Surgery, continued
- nevi, including spider, epidermal and protruding; .
- . neurofibromas;
- laser de-epithelialization; .
- . tricoepitheliomas;
- xanthelasma palpebrarum; .
- syringoma .
Laser ablation, vaporization and for excision for complete or partial nail matrixectomy.
Vaporization/coagulation of:
- � benign/malignant vascular/avascular skin lesions;
- . Moh's Surgery;
- . Lipectomy;
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungaual 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.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of 10
ਜੋਵਿੰਧ
క్రిశో
16
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
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;
- fungal nail treatment; .
- . porokeratoma ablation:
- . ingrown nail treatment;
- . neuromas/fibromas, including Morton's neuroma;
- debridement of ulcers:
- . other soft tissue lesions.
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- ◆ choanal atresia,
- leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue; .
- nasal obstruction: ●
- . adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages; .
- lymphangioma removal; .
- . removal of vocal cord/fold nodules, polyps and cysts;
- 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:
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 4 of 10
155 ---
17
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Otolaryngology (ENT), continued
- laser/tumor surgery in the larvnx, pharvnx, nasal, ear and oral structures and tissue; . ●
- . Zenker's Diverticulum/pharvngoesophageal diverticulum fendoscopic laser-assisted esophagodivertuculostomy (ELAED)];
- . stenosis, including subglottic stenosis;
- . tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
- pulmonary bronchial and tracheal lesion removal;
- . benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial);
- . benign and malignant lesions and fibromas (nose and nasal passages);
- benign and malignant tumors and fibromas; (oral); .
- stapedotomy/stapedectomy; .
- . acoustic neuroma in the ear;
- . superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease;
- telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or . upper lateral pharyngeal tissue);
- cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion . impairment), and cordal lesions of larynx, pharynx and trachea;
- . myringotomy/tympanostomy (tympanic membrane fenestration);
- . uvulopalatoplasty (LAUP, laser UPP);
- . turbinectomy and turbinate reduction/ablation);
- . septal spur ablation/reduction and septoplasty;
- . partial glossectomy:
- tumor resection on oral, subfacial and neck tissues; ●
- rhinophyma;
- verrucae vulgares (warts); .
- gingivoplasty/gingivoctomy. . .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
18
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
- conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and ● vaginal intraepithelial neoplasia (VIN, VAIN);
- condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, ● (Erythroplasia 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;
- . cervical dysplasia:
- benign and malignant tumors;
- hemangiomas. .
GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
- endometrial lesions, including ablation of endometriosis; .
- excision/lysis of adhesions;
- . salpingostomy;
- . oophorectomy/ovariectomy;
- fimbroplasty;
- metroplasty;
Prescription Use
-
microsurgery (tubal);
(Part 21 CFR 801 Subpart D) -
uterine myomas and fibroids; .
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 6 of 10
19
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2TM Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
GYN Laparoscopy, continued
- ovarian fibromas and follicle cysts; .
- uterosacral ligament ablation; ●
- hysterectomy. .
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
- posterior fossa tumors;
- . peripheral neurectomy;
- benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal . tumors), acoustic neuromas, lipomas and large tumors);
- . arteriovenous malformation:
- pituitary gland tumors (transphenoidal approach). .
Spinal Cord
- incision/excision and vaporization of benign and malignant tumors and cysts; ●
- . intra- and extradural lesions;
- laminectomy/ laminotomy/ microdiscectomy. .
イ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
20
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy
- . menisectomy;
- chodromalacia; ●
- chondroplasty; ●
- ligament release (lateral and other); .
- excision of plica; .
- . partial synovectomy.
General
- deridement of traumatic wounds; .
- debridement of decubitus and diabetic ulcers; ◆
- . microsurgery;
- . artificial joint revision;
- . PMMA removal.
General/Thoracic Surgery
Incision, excision and vaporization and 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;
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
21
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
General/Thoracic Surgery, continued
- reduction mammoplasty; .
- . cytoreduction for metastatic disease;
- laparotomy and laparoscopic 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/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; ●
- Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 9 of 10
391
22
510(k) Number (if known): K10
Device Name: Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories
Indications for Use - Continued from the previous page:
Dental/Oral Surgery, continued
- 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 and of soft tissue in genitourinary procedures. Applications include:
-
. benign and malignant lesions of external genitalia;
V -
. condyloma;
-
. phimosis
-
. erythroplasia.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 10 of 10