The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, and orthopedics, and otolaryngology (ENT).

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the performance of specific surgical applications in gastroenterology, neurosurgery, general surgery, genitourinary (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, and orthopedics, and otolaryngology (ENT) as follows:

Gastroenterology
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include:

hemostasis of esophageal varices;
palliation of malignant dysphagia;
palliative ablation of obstructive neoplasms;
hemostasis of colonoscopy.

Neurosurgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include:

tumors adjacent to the spinal cord;
tumors adjacent to the cortex.

General Surgery
Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.
The ablation, vaporization, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include:

Laparoscopic
- appendectomy;
- cholecystectomy;
- bowel resection.
Open
- mastectomy;
- reduction mammoplasty;
- breast biopsy;
- rectal and anal hemorrhoidectomy;
- bowel resection;
- colectomy;
- cholecystectomy;
- liver resection;
- condyloma;
- thyroidectomy;
- thoracotomy;
- cavernous hemangioma.

Genitourinary (Urology)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include:

Transurethral
- transurethral incision of the prostate (TUIP);
- bladder tumors;
- bladder neck incisions;
- urethral strictures;
- exterior sphincterotomy.
Laparoscopic
- Lymphadenectomy.
Open
- condyloma;
- circumcision
- benign and malignant lesions of external genitalia.

Thoracic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include:

pulmonary resection;
coagulation of blebs and bullae;
adhesiolysis;
pericardiectomy
mediastinal and thoracic lesions and abnormalities;
mediastinal lymph node dissection;
hemostasis;
thoracotomy.

Gynecology (GYN)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include:

Laparoscopic
- excision/lysis of adhesions;
- endometrial lesions, including ablation of endometriosis;
- laparoscopic assisted hysterectomy (LAVH);
- laser uterosacral nerve ablation (LUNA);
- myomectomy;
- ovarian cystectomy;
- ovarian drilling;
- tubal fimbrioplasty;
- appendectomy.
Open
- 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.
Intrauterine
- Fibroids/polyps/adhesions;
- Resection of septum.

Pulmonology
The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include:

tracheal bronchial lesions.

Ophthalmology
The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include:

Oculoplastics
- open DCR;
- endo-nasal DCR;
- tumor excision and biopsy;
- eyelid reconstruction;
- blepharoplasty.

Orthopedics
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include:

Open
- Dissect and coagulate.

Otolaryngology (ENT)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include:

Nasal/Sinus
- turbinectomy and turbinate reduction/ablation;
- polypectomy of nose and nasal passages;
- ethmoidectomy;
- meatal antrostomy;
Laryngo-tracheal
- removal of vocal cord/fold nodules, polyps and cysts;
- arytenoidectomy;
- tracheal stenosis;
Oropharyngeal
- uvulopalatoplasty (LAUP, laser UPPP);
- tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil;
- hemi glossectomy;
Head & Neck
- tumor resection on oral, subfacial and neck tissues;
- parathyroidectomy;
- thyroidectomy.

Device Description

The PhotoMedex LaserPro 810, 940 and 980 Diode Laser Systems are designed to provide laser power at wavelengths of 810mm, 940mm, and 980mm, depending on model, which can be used for the procedures indicated in the next section of this summary. These devices have been cleared previously via K040294. Differences between the cleared and modified device are limited to:

Maximum output power increased from 20 to 25 Watts (Systems are identified by output frequency and maximum power).
User adjustable (intensity) aiming beam (the maximum aiming beam optical power does not change from currently cleared device).

The system is comprised of the following main components:

A laser console/cabinet with fiber port to accept SMA-905 connectors.
Display panel with soft-touch keypad control and separate Emergency Off button.
Laser system microprocessor control electronics with operating software
A detachable covered footswitch.

AI/ML Overview

The provided document is a 510(k) Summary for the PhotoMedex LaserPro 810, 940 and 980 Systems Diode Laser Systems, submitted to the FDA for premarket notification. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove safety and effectiveness.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical study for several reasons:

Substantial Equivalence: The submission is based on the concept of "substantial equivalence" to previously cleared devices (K040294, K023543, K954316, K952661). This means PhotoMedex is asserting that their modified devices (with increased maximum output power and user-adjustable aiming beam) are as safe and effective as the predicate devices, and perform similarly. They are not introducing "new clinical indications" that would necessitate new performance criteria or efficacy studies.
Safety and Effectiveness Justification: Section 7, "SAFETY AND EFFECTIVENESS," explicitly states: "The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed... with both mandatory and voluntary and voluntary Standards ensuring when used with marketed cleared delivery systems identified to be chisating when are considered both safe and effective for the medical applications indicated. No new clinical indications are to be provided by the introduction of LaserPro Diode Surgical Lasers as compared to the identified predicates, which havel previously demonstrated clinical effectiveness." This indicates that the safety and effectiveness are established by adherence to standards and the prior clearance of predicate devices for similar indications.
No Clinical Study Details: The document makes no mention of any new human subject clinical trials, test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance studies. These are typically associated with novel devices or significant changes requiring new performance validation.

Given the nature of a 510(k) for minor modifications to an existing device and the explicit statements in the document, it is not possible to extract the requested information. The "study that proves the device meets the acceptance criteria" in this context is implicitly the historical data and regulatory clearances of the predicate devices.

Summary

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NOV - 8 2004

510(k) SUMMARY

K042211

PhotoMedex, Inc.

LaserPro 810, 940 and 980 Systems Diode Laser Systems

1. GENERAL

•	Submitter:	PhotoMedex, Inc.
		147 Keystone Drive
		Montgomeryville, PA, 18936

Bob Rose Contact Person: .
August 13, 2004 (Revised September 15, 2004) Date Prepared: .

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: Diode laser .
Trade or proprietary name: LaserPro Diode Surgical Laser System .

3. PREDICATE DEVICE (Device to be Modified)

Diode Surgical Laser Systems

PhotoMedex LaserPro 810, 940 and 980 Diode Laser Systems (K040294) ◆

4. DEVICE DESCRIPTION and DEVICE MODIFICATIONS

- Maximum output power increased from 20 to 25 Watts (Systems are identified by output frequency and maximum power).
· User adjustable (intensity) aiming beam (the maximum aiming beam optical power does not change from currently cleared device).

The system is comprised of the following main components:

A laser console/cabinet with fiber port to accept SMA-905 connectors. .
Display panel with soft-touch keypad control and separate Emergency Off . button.
Laser system microprocessor control electronics with operating software ●
A detachable covered footswitch. .

XVIII-2

{1}------------------------------------------------

5. INDICATIONS FOR USE

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems (and the fiber delivery systems and accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, maision, incision, and coagulation of soft tissue in medical specialties including:

Gastroenterology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices, palliation of malignant dysphagia, palliative ablation of obstructive neoplasms, hemostasis of colonoscopy.

Neurosurgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord, tumors adjacent to the cortex.

General Surgery

Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic appendectomy, cholecystectomy, and bowel resection. Open: mastectorny, reduction mammoplasty, breast biopsy, rectal and anal hemorrhoidectomy, bowel resection, colectorny, cholecystectorny, liver resection, condyloma, thyroidectorny, thoracotomy, and cavemous hemangioma.

Genitourinary (Urology)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral incision of the prostate (TUIP), bladder tumors, bladder neck incisions, urethral strictures, and exterior sphincterotomy. Laparoscopic lymphadenectomy. Open; condyloma, circumcision, and benign and malignant lesions of external genitalia.

Thoracic Surgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection, coagulation of blebs and bullae, adhesiolysis, pericardiectomy, mediastinal and thoracic lesions and abnormalities, mediastinal lymph node dissection, and hemostasis, thoracotomy.

XVIII-3

{2}------------------------------------------------

Premarket Notification: LaserPro@ 810. 940 and 980 Diode Laser Systems

Gynecology (GYN)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic, excision/lysis of adhesions, endometrial lesions, including ablation of endometriosis, laparoscopic assisted hysterectomy (LAVH), laser uterosacral nerve ablation (LUNA), myomectomy, ovarian cystectomy, ovarian drilling, tubal fimbrioplasty, and appendectomy. Open: 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. Intrauterine; fibroids/polyps/adhesions, resection of septum.

Pulmonology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.

Opthomology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics, open DCR, endo-nasal DCR, tumor excision (and) biopsy, eyelid reconstruction, and blepharoplast,

Orthopedics

The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthoped surgery procedures. Applications include: dissect and coagulate.

Otolaryngology (ENT)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus; turbinectorny and turbinate reduction/ablation, polypectomy of nose and nasal passages, ethmoidectomy, and meatal antrostomy. Laryngo-tracheal; removal of vocal cord/fold nodules, polyps and cysts, arytenoidectomy, and tracheal stenosis. Oropharyngeal; uvulopalatoplasty (LAUP, laser UPPP), tonsillectomy (including tonsillar cryptolysis, neoplasma) tonsil, and hemi glossectomy. Head & Neck; tumor resection on oral, subfacial and neck tissues, parathyroidectomy, and thyroidectomy.

6. SUBSTANTIAL EQUIVALENCE

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems, when used in conjunction with cleared delivery accessories, share the same indications for use, similar design features, functional features, and therefore are substantially equivale to the predicate devices which includes the Diomed D15 & D30 Laser Systems (K023543), the Premier Aurora Laser System (K954316), and the SLT Thermalite 810, 940 & 980 Laser Systems (K952661).

XVIII-4

{3}------------------------------------------------

7. SAFETY AND EFECTIVENESS

The PhotoMedex LaserPro 810. 940 and 980 Diode Laser Systems are designed, t the I notornounce with both mandatory and voluntary and voluntary Standards ensuring when used with marketed cleared delivery systems identified to be chisating when are considered both safe and effective for the medical applications indicated. No new clinical indications are to be provided by the introduction of LaserPro Diode Surgical Lasers as compared to the identified predicates, which havel previously demonstrated clinical effectiveness.

8. CONCLUSIONS

PhotoMedex believes that the (minor) modifications to the LaserPro 810. 940 and 980 I hotorious believes are substantially equivalent to, and are safe and effective as the Legally marketed identified predicate devices, the LaserPro 810, 940 and 980 Diode Laser Systems (K040294), in that they share identical mechanisms for laser energy delivery and indications for use.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that suggest movement or flight. The seal is black and white.

NOV - 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert Rose Director of Regulatory Affairs and Quality Assurance PhotoMedex, Inc., 147 Keystone Drive Montgomeryville, Pennsylvania 18936

Re: K042211

Ko42211
Trade/Device Name: LaserPro 810, 940 and 980 Surgical Diode Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 13, 2004 Received: August 16, 2004

Dear Mr. Rose:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications ferenced above and harrsure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to regions of the Medical Device Amendments, or to conimered process to may 20, 2017 11:11 in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmeter Fer (110) inst the device, subject to the general controls provisions of the Act. The r ou may, merelore, manns of the Act include requirements for annual registration, listing of general controls provision 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 rr your device is elabilition (see as courols. 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 thany 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 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.

{5}------------------------------------------------

Page 2 - Mr. Robert Rose

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you'll finding of substantial equivalence of your device to a legally premarket notification. The PDF interessification 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 If you desire spocently arrive ior your and (240) 276-0115. 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 other general mionmational 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

{6}------------------------------------------------

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: LaserPro 810, 940 and 980 Surgical Diode Laser Systems

Indications For Use:

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems The PhotoMedex Laserro 810, 940 and 960 burgious Drouse in survicel applications requiring the including and accessories used to deliver laser energy, are multation of soft tissue in medical specialites including: ablation, vaportzation, excision, incision, and coaganator or orders ), genecology (GYN), neurosurgery, gastroenterology, gelleral surgery, gentournial y carges) ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the The PhotoMedex LaserPro 310, 940 and 900 bargetters of the surgery, genitouring surgery performance of specific surgical applications in gasa one organizations of the openitialmology, pulmonology, and thoracic surgery as follows:

Gastroenterology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include:

hemostasis of esophageal varices; -
palliation of malignant dysphagia; -
palliative ablation of obstructive neoplasms; ー
hemostasis of colonoscopy. -

*** Page 1 of 6 (Indications For Use Continued on Next Page; 6 pages total) ***

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use _ (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

{7}------------------------------------------------

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: LaserPro 810, 940 and 980 Surgical Diode Laser Systems

Indications For Use:

Continued from previous page:

Neurosurgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include:

tumors adjacent to the spinal cord; -
tumors adjacent to the cortex. -

General Surgerv

Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include:

Laparoscopic ﺗ
- appendectomy; ,
- cholecystectomy; -
- bowel resection. ,
Open
- i mastectomy;
- reduction mammoplasty; ।
- breast biopsy;
- rectal and anal hemorrhoidectomy; -
- bowel resection; -
- colectomy; -
- cholecystectomy; -
- liver resection; -
- condyloma; -
- thyroidectomy; -
- thoracotomy; -
- cavemous hemangioma. -

*** Page 2 of 6 (Indications For Use Continued on Next Page; 6 pages total) ***

{8}------------------------------------------------

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: LaserPro 810, 940 and 980 Surgical Diode Laser Systems

Indications For Use:

Continued from previous page:

Genitourinary (Urology)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include:

Transurethral ..
- transurethral incision of the prostate (TUIP); ・
- bladder tumors; -
- bladder neck incisions; -
- urethral strictures; -
- exterior sphincterotomy. -
Laparoscopic -
- Lymphadenectomy. ।
Open
- condyloma; ,
- circumcision ।
- benign and malignant lesions of external genitalia. -

Thoracic Surgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include:

pulmonary resection; ー
coagulation of blebs and bullae; -
adhesiolysis; -
pericardiectomy .
mediastinal and thoracic lesions and abnormalities; -
mediastinal lymph node dissection; –
hemostasis; «
thoracotomy. -

*** Page 3 of 6 (Indications For Use Continued on Next Page; 6 pages total) ***

{9}------------------------------------------------

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________ K042211_

Device Name: LaserPro 810, 940 and 980 Surgical Diode Laser Systems

Indications For Use:

Continued from previous page:

Gynecology (GYN)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include:

Laparoscopic
- excision/lysis of adhesions; -
- endometrial lesions, including ablation of endometriosis; -
- laparoscopic assisted hysterectomy (LAVH); -
- laser uterosacral nerve ablation (LUNA); -
- myomectomy; -
- ovarian cystectomy; -
- ovarian drilling; -
- tubal fimbrioplasty; -
- appendectomy. -
Open
- en । vaginal intraepithelial neoplasia VIN, VAIN;
- vagnal intraceptinental nooplaste cervical, genital, vulvar, perineal, and Bowen's disease, -(Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions.
Intrauterine -
- Fibroids/polyps/adhesions; -
- Resection of septum. -

Pulmonology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include:

tracheal bronchial lesions. ।

{10}------------------------------------------------

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________ K042211 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: LaserPro 810, 940 and 980 Surgical Diode Laser Systems

Indications For Use:

Continued from previous page:

Opthomology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include:

Oculoplastics
- open DCR; 1
- endo-nasal DCR; -
- tumor excision and biopsy; -
- eyelid reconstruction; -
- blepharoplasty.

Orthopedics

The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include:

Open -
- Dissect and coagulate. -

{11}------------------------------------------------

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________ K042211

Device Name: LaserPro 810, 940 and 980 Surgical Diode Laser Systems

Indications For Use:

Continued from previous page:

Otolaryngology (ENT)

The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include:

Nasal/Sinus
- turbinectomy and turbinate reduction/ablation; -
- polypectomy of nose and nasal passages; -
- ethmoidectomy; -
- meatal antrostomy; -
Laryngo-tracheal
- removal of vocal cord/fold nodules, polyps and cysts; -
- arytenoidectomy; -
- tracheal stenosis; -
Oropharyngeal
- uvulopalatoplasty (LAUP, laser UPPP); -
- tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; ・
- hemi glossectomy; -
Head & Neck
- tumor resection on oral, subfacial and neck tissues; -
- parathyroidectomy; ・
- thyroidectomy. …

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number K042211

*** Page 6 of 6 (Indications For Use Continued on Next Page; 6 pages total) ***

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.