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. 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; 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 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.

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; laser/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.

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; 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.

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; 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; 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.

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: 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Alma Lasers Pixel CO2™ Laser System, Delivery Devices and Accessories:

Observation: The provided documentation is a 510(k) Premarket Notification from the FDA. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific performance metrics and acceptance criteria. Therefore, the document does not contain details about acceptance criteria, efficacy studies with sample sizes, expert ground truth establishment, or MRMC comparative effectiveness studies in the way one might expect for a de novo submission or a device claiming a novel mechanism of action.

The key to this submission is the claim of "substantial equivalence" to a predicate device, which implies that the new device is as safe and effective as the predicate without requiring new clinical performance data to establish specific metrics.

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the Alma Lasers Pixel CO2™ Laser System. Instead, it relies on demonstrating substantial equivalence to a predicate device, the Alma Lasers ThermoXEL™ CO2 Laser System and Delivery Device Accessories (K080463).

The "performance" of the device is implicitly accepted if it performs similarly to the predicate device for the stated indications. The rationale for substantial equivalence is based on the following similarities:

Acceptance Criterion (Implied by Substantial Equivalence)	Reported Device Performance
Same intended use and indications for use	Met (Identical)
Same operating principle (technology)	Met
Same basic design	Met
Same materials	Met
Packaged using the same materials and processes	Met

Explanation: In a 510(k) pathway, the "acceptance criteria" are effectively met if the new device can demonstrate that it shares fundamental characteristics and functions in a sufficiently similar manner to a previously cleared predicate device, and thus does not raise new questions of safety or effectiveness. The reported performance is that it is substantially equivalent based on these shared attributes.

Study Information (Based on 510(k) Content):

Sample size used for the test set and the data provenance:
- Test Set: No specific test set of patient data, images, or clinical outcomes is mentioned or used to evaluate the device's performance against specific acceptance criteria. The comparison is primarily technical and functional against the predicate device.
- Data Provenance: Not applicable, as no such test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no test set requiring ground truth established by experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a laser system, not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical laser system, not an algorithm, and no standalone performance testing in this context is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth was established as there was no test set of patient data.
The sample size for the training set:
- Not applicable. This is a physical medical device. The "training" for such a device would relate to engineering design, testing, and manufacturing quality, not a machine learning training set.
How the ground truth for the training set was established:
- Not applicable, as no training set (in the machine learning sense) is relevant for this type of device submission.

Conclusion on the provided text:

The document is a regulatory approval letter for a 510(k) premarket notification. Its purpose is to demonstrate "substantial equivalence" of the new device to a predicate device, not to present a comprehensive study with quantitative acceptance criteria and detailed performance data against specific clinical outcomes in the manner that might be expected for a novel efficacy claim, especially for AI/ML devices. Therefore, most of the requested information about acceptance criteria, study design, and ground truth is not present in this type of regulatory submission. The "study" for this submission is essentially the demonstration of technical and functional equivalence to the predicate device.

Summary

{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

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 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}------------------------------------------------

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}------------------------------------------------

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}------------------------------------------------

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)

signature
(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) OwnerAddress andEstablishmentRegistration #	Sponsor
	Alma Lasers, Inc.485 Half Day Rd. Suite No. 100Buffalo Grove, IL 60089, USAFDA Registration #: 3004167969
	Tatiana EpsteinVP QA&RAAlma Lasers, Inc.	Telephone:Facsimile:Email:	(224) 377-2011(224) 377-2050tatianae@almalasers.com
Contact Person:	Main Contact:Tatiana EpsteinVP QA&RAAlma Lasers, Inc.	Telephone:Facsimile:Email:	(224) 377-2011(224) 377-2050tatianae@almalasers.com
	Secondary Contact:Avi FarbsteinEVP 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.):

1. 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}------------------------------------------------

1. LCD control panel with touch-screen technology
1. 7-joint articulated arm
Footswitch 9.
1. 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

Regulation Number and Section

§ 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.