LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
Device Facts
| Record ID | K040234 |
|---|---|
| Device Name | LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM |
| Applicant | Photo Medex, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Apr 2, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PhotoMedex LaserPro CO2 Carbon Dioxide Laser System, when used with the delivery accessories identified in the Users Instructions (used to deliver laser energy), is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The LaserPro CO2 Surgical Laser is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: Laser skin resurfacing; Laser derm-abrasion; Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for treatment of: wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
Device Story
LaserPro CO2 Carbon Dioxide Laser System; delivers 10,600nm infrared laser energy for soft tissue surgery. System components: laser console, console tower, display panel with soft-touch keypad, microprocessor control electronics, counterbalanced articulated arm, detachable footswitch. Used in clinical settings (OR, clinic) by physicians. Operator selects parameters via keypad; laser energy delivered through articulated arm and compatible accessories (handpieces, scanners, micromanipulators). Provides precise ablation, vaporization, excision, and coagulation; enables minimally invasive procedures (endoscopic/laparoscopic) and open surgery. Benefits: improved surgical precision, hemostasis, and reduced tissue trauma compared to traditional methods.
Clinical Evidence
Bench testing only. Device performance verified against mandatory and voluntary standards including 21 CFR 1040.10 & 1040.11, Quality System Regulation (21 CFR Part 820), EN60601-1, EN60601-1-2, EN60601-2-22, EN 60601-1-4, EN ISO 14971, IEC60825, and UL2601-1/UL60601-1. No new clinical data provided; clinical effectiveness is supported by equivalence to predicate devices.
Technological Characteristics
CO2 laser source; 10,600nm wavelength. Components: console, articulated arm, footswitch. Microprocessor-controlled electronics. Standards: 21 CFR 1040.10/1040.11, EN60601-1, EN60601-1-2, EN60601-2-22, EN 60601-1-4, EN ISO 14971, IEC60825, UL2601-1/UL60601-1. Connectivity: standalone system with keypad interface.
Indications for Use
Indicated for patients requiring soft tissue ablation, vaporization, excision, or coagulation across specialties: dermatology, plastic surgery, podiatry, ENT, gynecology (including laparoscopy), neurosurgery, orthopedics, arthroscopy, general/thoracic surgery, dental/oral surgery, and genitourinary surgery. Specific applications include skin resurfacing, lesion removal, tumor resection, and various endoscopic/open surgical procedures.
Regulatory Classification
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.
Predicate Devices
- Lumenis Modified Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147)
- Lumenis UltraPulse Encore Carbon Dioxide Laser and Delivery Device Accessories (K022060)
Submission Summary (Full Text)
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K040234 1 of 3
#### APR - 2 2004 510(k) SUMMARY PhotoMedex, Inc. LaserPro CO2 Carbon Dioxide Laser System
## 1. GENERAL
- Submitter: PhotoMedex, Inc. . 147 Keystone Drive Montgomeryville, PA, 18936
- Contact Person: Bob Rose .
- Date Prepared: January 30, 2004 .
## 2. DEVICE NAME
- · Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810)
- Common or usual name: Carbon dioxide laser .
- Trade or proprietary name: LaserPro CO2 Carbon Dioxide Laser System .
## 3. PREDICATE DEVICES
Carbon Dioxide Laser Systems:
- Lumenis Modified Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147) .
- Lumenis UltraPulse Encore Carbon Dioxide Laser and Delivery Device Accessories . (K022060)
## 4. DEVICE DESCRIPTION
The PhotoMedex LaserPro CO2 carbon dioxide laser system is designed to provide infrared laser power at a wavelength of 10,600nm which can be used for the procedures indicated in the next section. The system is comprised of the following main components:
- A laser console .
- . A laser console tower
- Display panel with soft-touch keypad control and separate Emergency Off button. .
- Laser system microprocessor control electronics with operating software .
- A seven segment counterbalanced articulated arm designed to accept the delivery . accessories defined in CHART A located in the next section.
- A detachable covered footswitch. .
XVIII- 2
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# K040234
510(k): Premarket Notification LaserPro® CO2 Carbon Dioxide Laser System
## 5. INDICATIONS FOR USE
The Photomedex LaserPro CO2 Carbon Dioxide Laser System, when used in conjunction The Photomedex Lasen To CO2 Carbon Droxies Last is designed to deliver light energy and with the identified delivery accosser.com (or ablation, vaporization, vaporization, excision, is includion for use in bargreat upper.
incision, and coagulation of soft tissue in medical specialties including: aesthetic Including and plastic surgery), podiatry, otolaryngology (ENT), gyneology (including
(dermatology and plastic surgery), podiatry, otolaryngology (including (definatology and prastis sargery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitouring on thoracic surgery (mending open and one one one one one of the maintend for use surgely. Additionally, the Easer to Secondo Specialties including: aesthetic (dermatology and In specific surgical approamons in mostus ent. In the surecology (including laparoscopy), plastic surgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery fiedrostligery, orthopodios (only issental and oral surgery and genitourinary surgery.
| Delivery Systems Used With the<br>PhotoMedex LaserPro™ CO2 Carbon<br>Dioxide Laser System | Manufacturer's<br>Model Number | Premarket Notification<br>Clearance Number |
|-------------------------------------------------------------------------------------------|--------------------------------|--------------------------------------------|
| Acutome® 100 CO2 Laser Handpiece | 0200-033-01 | K942935 |
| Accuscan® CO₂ Laser Scanner | 0200-216-01 | K953670 |
| Acutome® 2000 CO2 Laparoscopic<br>Coupler | 0200-044-01 | K942868 |
| Unimax® 2000 CO2 Micromanipulator | 0200-009-01C | K920821 |
CHART A: Delivery Accessories to be used with the LaserPro CO2 Carbon Dioxide Laser System
## 6. SUBSTANTIAL EQUIVALENCE
The Photomedex LaserPro CO2 Carbon Dioxide Laser System, when used in conjunction The I notomedex Eason 10 OO] Ca.org (CHART A) share the same indications for use, while themiliou denvery accessories, and therefore are substantally equivalent to the similar design realatos, Innotional the Lumenis Modified Family of UltraPulse SurgiTouch predicate devices which moracos are & Lumenis UltraPulse Encore Carbon Dioxide Laser COJ Laser Systems (R022064). In addition, a review of the predicate devices alle Delivery Dories LaserPro CO2 Carbon Dioxide Laser System, when used ucmonistrates that the I notemedad elivery accessories is safe and effective as the predicate in collunetion with the rusial wavelengths, and are used to perform the same indicated surgical procedures.
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K040234/ 3 of 3
510(k): Premarket Notification LaserPro® CO2 Carbon Dioxide Laser System
## 7. SAFETY AND EFECTIVENESS; PRODUCT PERFORMANCE
The Photomedex LaserPro CO2 Carbon Dioxide Laser System is designed, tested and will be The Photomedex LaserPro CO1 Caroni Dioxico Land Voluntary standards, including 21 CFR
manufactured in accordance with both mandatory and voluntary standards, 1 CFR 1040.10 & 1040.11, PART 820 = Quality System Regulation, EN60601-1, EN60601-1-2,
1040.10 & 1040.11, PART 820 = Quality System Regulation, EN60601-1 1040.10 & 1040.11, 1 ART 820 - Quanty Bysteiner C660825, and, UL2601-1 / UL60601-1
EN60601-2-22, EN 60601-1-4, EN ISO 14971, IEC60825, 4CHART AN that it is both a EN60601-2-22, EN 00001-1-4, EN ISO 11777, accessories (CHART A), that it is both safe ensuring when used with the lucitired deliver. No new clinical indications are to be
and effective for the medical applications indications are to be and effective for the medical applications increases. " Piction Caser System as compared to
provided by the introduction of LaserPro CO2 Carbon Diesel offectiveness to the us provided by the introduction of Easteriously demonstrated clinical effectiveness to the uses indicated.
## 8. CONCLUSIONS
Based on the information reviewed and provided within this application, PhotoNecles Based on the information reviewed and provided withing is substantially equivalent to,
believes that the LaserPro CO2 Carbon Dioxide Laser System is substantially equivalent believes that the Last 10 CO2 Carbon 270 Cardicate devices, the Lumenis Modified and is safe and effective as the regary marked provins (K030147) and the Lumenis UltraPulse Family of Uitaruise Surgirouch CO7 Laser Byotonia (K022060) in that they share Encore Carbott Dioxido Easer and reason and indications for use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 2 2004
Mr. Bob Rose Director of Regulatory Affairs and Quality Assurance PhotoMedix, Inc. 147 Keystone Drive Montgomervville, Pennsylvania 18936
Re: K040234
Trade/Device Name: LaserPro® CO2 Carbon Dioxide Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 30, 2004 Received: February 2, 2004
Dear Mr. Rose:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicc 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.
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Page 2 - Mr. Bob Rose
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## 510(k) Number (if known): K040234
### Device Name: LaserPro® CO2 Carbon Dioxide Laser System
Indications For Use:
The PhotoMedex LaserPro CO2 Carbon Dioxide Laser System, when used with the delivery accessories identified in the Users Instructions (used to deliver laser energy), is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
The LaserPro CO2 Surgical Laser is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:
#### Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- Laser skin resurfacing; -
- Laser derm-abrasion; ।
- Laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for treatment of:
- wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
> Concurrence of CDRH, Office of Device Evaluation (ODE) miriam C Trovost
> > (Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 7 (Indications For Use Continued on Next Page; 7 pages total)
510(k) Number K640234
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## 510(k) Number (if Known): K040234
### Device Name: LaserPro® CO2 Carbon Dioxide Laser System
Indications For Use: Continued from 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 homs;
- solar/actinic clastosis; -
- cheilitis, including actinic cheilitis; -
- lentigines, including lentigo maligna or Hutchinson's malignant freckle;
- uneven pigmentation/ dyschromia;
- acne scars;
- surgical scars; -
- keloids including acne keloidalis nuchae;
- hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum);
- tattoos:
- telangiectasia;
- removal of small skin tumors, including periungual (Koenen) and subungual fibmromas;
- superficial pigmented lesions;
- adenosebaceous hypertrophy or sebaceous hyperplasia;
- ー rhinophyma reduction;
- cutaneous papilloma (skin tags);
- ー milia;
- debridement of eczematous or infected skin: -
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Frythroplasia of -Queyrat), and Bowenoid Papulosis (BP) lesions;
- nevi, including spider, epidermal and protruding;
- neurofibromas;
- laser de-epithelialization: -
- tricoepitheliomas; -
- xanthelasma palpebrarurn; -
- syringoma
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### 510(k) Number (if Known): K040234
#### Device Name: LaserPro® CO2 Carbon Dioxide Laser System
Indications For Use: Continued from previous page:
#### Dermatology & Plastic Surgery, continued
Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy
Vaporization/coagulation of:
- Benign/malignant vascular/avascular skin lesions; -
- -Moh's Surgery:
- lipectomy:
- verrucae and seborthoecae vulgares, including paronychial, periungal, and subungual warts; -
Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
#### Podiatry
Laser ablation, vaporization and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; -
- fungal nail treatment;
- porokeratoma ablation; -
- ingrown nail treatment;
- neuromas/fibromas, including Morton's neuroma; -
- debridement of ulcers; -
- other soft tissue lesions.
#### Genitourinary
Incision, excision and vaporization of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia: -
- condyloma;
- phimosis; -
- erythroplasia
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## 510(k) Number (if Known): K040234
## Device Name: LaserPro® CO2 Carbon Dioxide Laser System
Indications For Use: Continued from previous page:
## Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of:
- choana1 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 esophagodiverticulostomy (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/endobronchia1);
- benign and malignant lesions and fibromas (nose and nasal passages); 1
- benign and malignant tumors and fibromas (oral); -
- stapedotomy/stapedectomy;
- acoustic neuroma in the ear; -
- superficial lesions of the car, incl. 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), ー 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/gingivectomy
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## 510(k) Number (if Known): K040234
Device Name: LaserPro® CO2 Carbon Dioxide Laser System
Indications For Use: Continued from previous page:
## Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology (GYN) for treatment of:
- conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN. VAIN):
- condyloma acuminata, 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; ー
- 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 ~
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### 510(k) Number (if Known): K040234
#### Device Name: LaserPro® CO2 Carbon Dioxide Laser System
Indications For Use: Continued from previous page:
#### Neurosurgery
Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of:
- . Cranial
- Posterior fossa tumors; l
- peripheral neurectomy;
- arteriovenous malformation; -
- benign and malignant tumors and cysts [e.g. gliomas, menigiomas (including basal tumors), -
- acoustic neuromas, lipomas and large tumors]; ー
- pituitary gland tumors (transsphenoidal approach) -
#### Spinal Cord
-
- incision/excision and vaporization of benign and malignant tumors and cysts; -
- -Intra- and extradural lesions;
- laminectomy/ laminotomy/ microdiscectomy
#### General and Thoracic Surgery
Incision, excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- debridement of decubitus ulcers, stasis, diabetic and other ulcers;
- mastectomy;
- debridement of burns; -
- rectal and anal hemorrhoidectomy; -
- breast biopsy: -
- reduction mammoplasty; -
- cytoreduction for metastatic disease;
- laparotomy and laparoscopic applications;
- skin tag vaporization; -
- ﯿﮯ atheroma;
- abscesses: ー
- other soft tissue applications
- mediastinal and thoracic lesions and abnormalities;
- cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; -
- pilonidal cyst removal and repair;
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## 510(k) Number (if Known): K040234
Device Name: LaserPro® CO2 Carbon Dioxide Laser System
Indications For Use: Continued from previous page:
## Orthopedics
Incision, excision and vaporization of soft tissue in orthopedic surgery. Applications include:
- Arthroscopy ﮯ
- menisectomy; -
- ・ chondromalacia;
- chondroplasty; -
- excision of plica; -
- partial synovectomy: -
- ligament release (lateral and other);
- General
- debridement of traumatic wounds; -
- debridement of decubitus and diabetic ulcers; -
- microsurgery: -
- artificial joint revision;
- -PMMA removal
### 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; -
- frenectomy (frenum release);
- treatment of ulcerous lesions, including aphthous ulcers;
- incision of infection when used with antibiotic therapy;
- excision and ablation of benign and malignant lesions; -
- homcostasis;
- operculectomy: -
- crown lengthening;
- removal of soft tissue, cysts and tumors;
- oral cavity tumors and hemangiomas;
- abscesses;
- extraction site hemostasis;
- ー salivary gland pathologies;
- preprosthetic gum preparation; -
- leukoplakia;
- partial glossectomy;
- periodontal gum resection
