(90 days)
No
The document describes a surgical laser system and its intended uses. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the laser technology itself and its application in various surgical procedures.
Yes
The device is indicated for use in various surgical applications to treat a wide range of medical conditions, including the ablation, vaporization, incision, and coagulation of soft tissue, which directly addresses therapeutic purposes.
No
The document describes a surgical laser system indicated for use in ablating, vaporizing, incising, and coagulating soft tissue, which are therapeutic applications rather than diagnostic procedures.
No
The device description explicitly lists hardware components such as a laser console, articulated arm, control panel, footswitch/handswitch, and an optional air purge pump system, in addition to operating software. This indicates it is a hardware-based medical device with accompanying software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a surgical laser system used for the ablation, vaporization, incision, and coagulation of soft tissue directly on the patient's body during surgical procedures.
- Intended Use: The intended use is for performing surgical applications in various medical specialties. It does not involve analyzing samples outside the body.
The device is a surgical tool, not a diagnostic one that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, incision, 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 Modified Lumenis Family of UltraPulse Surgical Lasers are 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, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- laser skin resurfacing;
- laser derm-abrasion;
- laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for treatment of: - wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the UltraPulse CO2 laser increases the amount of sub-epidermal collagen.
Dermatology & Plastic Surgery, continued
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica;
- vermillionectomy of the lip;
- cutaneous horns;
- solar/actinic elastosis;
- 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 fibromas;
- superficial pigmented lesions;
- adenosebaceous hypertrophy or sebaceous hyperplasia;
- rhinophyma reduction;
- cutaneous papilloma (skin tags);
- milia:
- debridement of eczematous or infected skin;
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
- nevi, including spider, epidermal and protruding;
- neurofibromas;
- laser de-epithelialization;
- tricoepitheliomas;
- xanthelasma palpebrarum;
- syringoma
Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy
Vaporization/coagulation of: - benign/malignant vascular/avascular skin lesions;
- Moh's Surgery;
- lipectomy;
- verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts:
Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
Podiatry
Laser ablation, vaporization and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
- 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 and partial matrixectomy;
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for 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 fendoscopic 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/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/gingivectomy
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:
- 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 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 of soft tissue in orthopedic surgery. Applications include:
Arthroscopy
- menisectomy;
- chondromalacia:
- chondroplasty;
- ligament release (lateral and other);
- excision of plica;
- partial synovectomy;
General
- debridement of traumatic wounds;
- debridement of dualifatio woulds;
debridement of decubitus and diabetic ulcers; and New - microsurgery;
- artificial joint revision;
- PMMA removal
General/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;
- 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 of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia;
- condyloma;
- phimosis;
- erythroplasia
Product codes
GEX
Device Description
The modified Lumenis family of UltraPulse SurgiTouch CO2 Laser Systems are comprised of the following main components:
- A laser console .
- A laser console tower .
- A counterbalanced articulated arm and delivery system .
- . Control and display panel
- System microprocessor control electronics .
- A covered footswitch or handswitch for specific delivery device accessories ●
- An optional air purge pump system with an insufflator filter for purge of delivery device . accessories
- Operating software .
- A variety of delivery device accessories or handpieces, including a pattern generator .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, nail matrix, ear, nose, nasal passages, larynx, uvula, palatal, upper lateral pharyngeal tissue, tongue, vocal cords, pharynx, trachea, tracheobronchial, endobronchial, cervix, vulvar, vaginal, Bartholin's and nubuthian cysts, urethral, endometrium, adhesions, uterine, ovarian, uterosacral ligament, brain (posterior fossa, pituitary gland), peripheral nerves, spinal cord, meninges, meniscus, cartilage, ligaments, joint (artificial), traumatic wounds, decubitus ulcers, diabetic ulcers, breast, rectum, anus, mediastinum, thoracic, oral cavity, gingiva, teeth, salivary glands, external genitalia.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Medical and clinical study information was provided to demonstrate that the modified Lumenis family of UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers are safe and effective, when indicated in specific applications in the medical specialties of 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Attachment 7 510(k) Summary Statement for the Modified Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems
I. General Information
APR 1 5 2003
| Submitter: | Lumenis, Inc.
2400 Condensa Street
Santa Clara, CA 95051 |
|---------------------------|----------------------------------------------------------------|
| Contact Person: | Anne C Worden
Regulatory Consultant |
| Summary Preparation Date: | January 12, 2003 |
II. Names
Device Names:
Modified Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems
Primary Classification Name: Laser Powered Surgical Instrument (and Accessories)
Predicate Devices III.
- · Lumenis Family of UltraPulse Encore CO2 Laser Systems (K022060);
- · Lumenis Family of UltraPulse CO2 Laser Systems (K963339).
Product Description IV.
The modified Lumenis family of UltraPulse SurgiTouch CO2 Laser Systems are comprised of the following main components:
- A laser console .
- A laser console tower .
- A counterbalanced articulated arm and delivery system .
- . Control and display panel
- System microprocessor control electronics .
- A covered footswitch or handswitch for specific delivery device accessories ●
- An optional air purge pump system with an insufflator filter for purge of delivery device . accessories
- Operating software .
- A variety of delivery device accessories or handpieces, including a pattern generator .
V. Indications for Use
Lumenis UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers (and their delivery accessories) are used to deliver light energy and are 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.
1
In addition, the Lumenis UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers are safe and effective when indicated for use in specific surgical applications 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.
VI. Rationale for Substantial Equivalence
The modified Lumenis family of UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers (and their delivery accessories) share the same indications for use, similar design features. functional features, and therefore are substantially equivalent to the predicate devices, including the Lumenis UltraPulse Encore CO2 Surgical Laser Systems (K022060) and the Lumenis (formerly Coherent Medical Group) UltraPulse CO2 Surgical Laser Systems In addition, medical and clinical data demonstrated that UltraPulse (K963339). SureiTouch Carbon Dioxide Surgical Lasers are safe and effective when indicated for use of additional specific applications in a variety of medical specialties.
Safety and Effectiveness Information VII.
Medical and clinical study information was provided to demonstrate that the modified Lumenis family of UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers are safe and effective, when indicated in specific applications in the medical specialties of 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.
VIII. Conclusion
The modified Lumenis family of UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers (and their delivery accessories) were found to be substantially equivalent to the predicate Lumenis family of UltraPulse Encore Carbon Dioxide Surgical Lasers (K022060), and to the Lumenis family of UltraPulse Carbon Dioxide Surgical Lasers (K963339). The modified Lumenis family of UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers share the same intended uses, similar indications for use, and identical technological characteristics, and thus are substantially equivalent to, the currently marketed predicate devices.
Medical and clinical study information was provided to demonstrate that the modified Lumenis family of UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers are safe and effective, when indicated in specific applications in the medical specialties of 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.
2
Image /page/2/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle with its wings spread, created with thick, flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2003
Ms. Anne C. Worden Regulatory Consultant Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051
Re: K030147
Trade/Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers 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 13, 2003 Received: January 15, 2003
Dear Ms. Worden:
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.
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 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.
3
Page 2 - Ms. Anne C. Worden
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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.
Marti N. Millikan
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
4
KO30147
Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known): K030147
Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
Indications For Use:
The Modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, incision, 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 Modified Lumenis Family of UltraPulse Surgical Lasers are 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, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- . laser skin resurfacing;
- laser derm-abrasion; .
- laser burn debridement. .
Laser skin resurfacing (ablation and/or vaporization) for treatment of:
- wrinkles, rhytids, and furrows (including fine lines and texture irregularities). ●
Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the UltraPulse CO2 laser increases the amount of sub-epidermal collagen.
*** Page 1 of 8 (Indications For Use Continued on Next Page; 8 pages total) ***
(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 General. Restorative
and Neurological Devices
| 510(k) Number | K030147 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
5
510(k) Number (if Known): K030147
Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
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 horns; .
- . solar/actinic elastosis;
- cheilitis, including actinic cheilitis; .
- lentigines, including lentigo maligna or Hutchinson's malignant freckle; ●
- uneven pigmentation/ dyschromia; ●
- acne scars;
- . surgical scars;
- keloids including acne keloidalis nuchae; .
- hemangiomas (including Buccal, port wine and pyogenic 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
Mark N. Milker
General. Restorative
510(k) Number K030147
*** Page 2 of 8 (Indications For Use Continued on Next Page; 8 pages total) ***
6
Image /page/6/Picture/3 description: The image shows the text "KO 30147" in a handwritten style. The letters and numbers are written in black ink on a white background. The letters "KO" are followed by the numbers "30147". The text appears to be a code or identification number.
K030147 510(k) Number (if Known):
Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
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 seborrhoecae vulgares, including paronychial, periungal, and subungual . warts:
Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation
Podiatry
Laser ablation, vaporization and/or excision of soft tissue for the reduction, removal, and/or treatment of:
- verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; .
- . 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 and partial matrixectomy;
Mark N Milliken
eral. Restorative
) Number K030147
*** Page 3 of 8 (Indications For Use Continued on Next Page; 8 pages total) **
7
000
Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known): K030147
Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
Indications For Use:
Continued from previous page:
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for 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 fendoscopic 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/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;
** Page 4 of 8 (Indications For Use Continued on Next Page; 8 pages total) ***
510(k) Submission: Modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
8
@00
K030147 510(k) Number (if Known):
Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
Indications For Use:
Continued from previous page:
Otolaryngology (ENT) - continued
- rhinophyma; ●
- . verrucae vulgares (warts);
- . gingivoplasty/gingivectomy
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: .
- 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
Mark N Millman
ivision Sign-Off) rision of Ceneral, Restorativ and Neurological Devices
10(k) Number K030147
- *** Page 5 of 8 (Indications For Use Continued on Next Page; 8 pages total) ***
9
LUMENIS INC
000
Attachment 2 Indications For Use Statement as Requested by FDA
K030147 510(k) Number (if Known):
Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
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; .
- 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 of soft tissue in orthopedic surgery. Applications include:
Arthroscopy
- menisectomy; ●
- chondromalacia: ●
- chondroplasty; .
- ligament release (lateral and other); .
- excision of plica; .
- . partial synovectomy;
General
- . debridement of traumatic wounds;
- debridement of dualifatio woulds;
debridement of decubitus and diabetic ulcers; and New . - microsurgery; .
- . artificial joint revision;
- PMMA removal
Mark N. Milkum
Restorative
710(k) Number K030147
*** Page 6 of 8 (Indications For Use Continued on Next Page; 8 pages total) ***
10
510(k) Number (if Known): K030147
Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
Indications For Use:
Continued from previous page:
General/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; .
- 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;
Mark A Milbern
Division of General. Restorative
710(k) Number K030147
*** Page 7 of 8 (Indications For Use Continued on Next Page; 8 pages total) **
510(k) Submission:
Modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
Attachment 2 - Page 7
11
Image /page/11/Picture/2 description: The image contains a sequence of alphanumeric characters, specifically "K030147". The characters are written in a clear, legible font, with each character distinctly formed. The sequence appears to be a code or identification number, possibly a serial number or product code.
@ 0 1
Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known): K030147
Device Name: Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers
Indications For Use:
Continued from previous page:
Dental/Oral Surgery - continued
- extraction site hemostasis; .
- salivary gland pathologies; ●
- preprosthetic gum preparation; .
- leukoplakia; .
- . partial glossectomy;
- periodontal gum resection .
Genitourinary
Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia; .
- condyloma; .
- phimosis; .
- . erythroplasia
Mark A. Milliken
Restorative