(55 days)
No
The summary describes a diode laser system for soft tissue surgery and does not mention any AI or ML capabilities.
Yes
The device is intended for various surgical procedures, including incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue across multiple anatomical sites, which are all therapeutic interventions aimed at treating or alleviating conditions.
No
The text describes the device's functions as surgical procedures like incision, excision, vaporization, ablation, and hemostasis of soft tissue, not for diagnosis.
No
The device description explicitly states "LaserTx™ - Diode Laser & Delivery System," indicating it is a hardware system (diode laser) with a delivery system, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Laser Ix Diode Laser System is intended for the delivery of laser light to soft tissue during surgical procedures. It is used on the patient's body (in vivo) for surgical interventions like incision, excision, vaporization, etc.
- Intended Use: The intended use describes surgical procedures performed directly on the patient, not laboratory testing of samples.
Therefore, based on the provided information, the Laser Ix Diode Laser System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Laser Ix Diode Laser System is intended for delivery of laser light to soft tissue in contact or non contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Laser Ix laser system is generally indicated for incision, excision Vaporization, ablation, hemostatis or coagulation of soft tissue In Ear, Nose and Throat and Oral surgery (Otolaryngology), Dental Procedures, Arthroscopy Gastroenterology, General Surgery, Dermatology Plastic surgery, Podiatry, Urology, Gynecology, Neurosurgery (Peripheral nervous system) Pulmonary surgery and cardiothoracic surgery. The Laser Tx Diode laser system can be used with fiber optic laser delivery devices and photosensitizing agents & chromophores to enhance target tissue effects and photo selective application during surgical procedures. The LaserTx Diode Laser system is indicated for incision, excision, vaporization, hemostatis coagulation, ablation of soft tissue, tumors, strictures, obstructions in body organs including urethra, bladder, prostate, uterus, breast, stomach, colon, abdomen, veins lung, brain, ear, nose throat etc. For additional indications for use please refer to attachment. (Additional Indications, identical to predicated device cleared by FDA under 510K application # K032864)
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- Removal of benign lesions from the ear, nose and throat
- Excision and vaporization of vocal cord nodules and polyps
- Incision and excision of carcinoma in situ
- Ablation and vaporization of hyperkeratosis
- Excision of carcinoma of the larynx
- Laryngeal papillomectomy
- Excision and vaporization of herpes simplex I and II
- Neck dissection
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy
- Synovectomy
- Chondromalacia
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
- Hemostasis of upper and lower GI bleeding
- Excision and vaporization of colorectal carcitioners
- Excision of polyps
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy
- Excision of neuromas
- Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids
- Liver resection
- Excision of cutaneous lesions
- Hemorrhoidectomy
- Appendectomy
- Debridement of decubitus ulcers
- Hepatobiliary tumors
- Mastectomy
- Dermabrasion
- Vaporization and homeostasis of capillary hemangioma
- Excision, vaporization and hemostasis of abdominal tumors
- Excision, vaporization and hemostasis of rectal pathology
- Pilonidal cystectomy
- Herniorapphy
- Adhesiolysis
- Parathyroidectomy
- Laparoscopic cholecystectomy
- Thyroidectomy
- Resection of organs
- Debridement of wounds
- Phototcoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities
Urology
Excision, vaporization, incision, coagulation, ablation and homeostasis of urological tissues. Examples include:
- Vaporization of urethral tumors
- Release of urethral stricture
- Removal of bladder neck obstruction
- Excision and vaporization of condyloma
- Lesions of external genitalia
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation
- Excision or vaporization of condylomata acuminata
- Vaporization of cervical intraepithelial neoplasia
- Cervical conization
- Menorrhagia
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: homeostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture
- Benign and malignant pulmonary obstruction
- Endoscopic pulmonary applications
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectory, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
Product codes (comma separated list FDA assigned to the subject device)
OCL, GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose and Throat, Oral cavity, Joints, Upper and lower gastrointestinal tracts, Skin, Abdominal soft tissue, Rectal soft tissue, Fat tissue, Muscle tissue, Urethra, Bladder, Prostate, Uterus, Breast, Stomach, Colon, Abdomen, Veins, Lung, Brain, External genitalia, Gynecological tissue, Cardiac tissue, Pulmonary system, Intraoral and extraoral soft tissue (gingival, epithelial lining of free gingival), Greater Saphenous Vein (GSV) of the thigh.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ProSurg, Inc. c/o Mr. Ashvin Desai Manager, Regulatory Affairs 2195 Trade Zone Boulevard San Jose. CA 95131
Re: K060326
Trade/Device Name: LaserTx™ - Diode Laser & Delivery 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 (two) Product Code: OCL, GEX Dated: February 2, 2006 Received: February 15, 2006
Dear Mr. Desai:
This letter corrects our substantially equivalent letter of April 5, 2006.
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 (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 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.
1
Page 2 - Mr. Ashvin Desai
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.
This letter will allow you to continue 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
ellmpell
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration. The text "U.S. Food and Drug Administration" is written in bold letters. Below this text, it says "Center for Devices and Radiological Health" in smaller letters. There is a logo on the left side of the text and another logo on the right side of the text.
Indications for Use
510(k) Number (if known): K060326
Device Name: LaserTx™ - Laser & Delivery System
Indications for Use:
The Laser Ix Diode Laser System is intended for delivery of laser light to soft tissue in contact or non contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Laser Ix laser system is generally indicated for incision, excision Vaporization, ablation, hemostatis or coagulation of soft tissue In Ear, Nose and Throat and Oral surgery (Otolaryngology), Dental Procedures, Arthroscopy Gastroenterology, General Surgery, Dermatology Plastic surgery, Podiatry, Urology, Gynecology, Neurosurgery (Peripheral nervous system) Pulmonary surgery and cardiothoracic surgery. The Laser Tx Diode laser system can be used with fiber optic laser delivery devices and photosensitizing agents & chromophores to enhance target tissue effects and photo selective application during surgical procedures. The LaserTx Diode Laser system is indicated for incision, excision, vaporization, hemostatis coagulation, ablation of soft tissue, tumors, strictures, obstructions in body organs including urethra, bladder, prostate, uterus, breast, stomach, colon, abdomen, veins lung, brain, ear, nose throat etc. For additional indications for use please refer to attachment. (Additional Indications, identical to predicated device cleared by FDA under 510K application # K032864)
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 OF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| file://F:\indicate.html | 3/31/2006 |
|---|---|
| ------------------------- | ----------- |
| 510(k) Number | K060326 |
|---|---|
| --------------- | --------- |
3
Page 2 of
510 (k) NUMBER (IF KNOWN) : K 060326
DEVICE NAME: LaserTxTM - Diode Laser & Delivery System
INDICATIONS FOR USE:
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- Removal of benign lesions from the ear, nose and throat す
- Excision and vaporization of vocal cord nodules and polyps
- Incision and excision of carcinoma in situ
- Ablation and vaporization of hyperkeratosis
- Excision of carcinoma of the larynx
- Laryngeal papillomectomy
- Excision and vaporization of herpes simplex I and II
- Neck dissection ◆
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy .
- Synovectomy ◆
- Chondromalacia ◀
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
- Hemostasis of upper and lower GI bleeding
- Excision and vaporization of colorectal carcitioners
- Excision of polyps
gmee
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
K060326 510(k) Number_
4
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy �
- Excision of neuromas ▲ Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids 4
- Liver resection �
- Excision of cutaneous lesions .
- Hemorrhoidectomy .
- Appendectomy .
- Debridement of decubitus ulcers 4
- Hepatobiliary tumors 사
- Mastectomy 한
- Dermabrasion 해
- Vaporization and homeostasis of capillary hemangioma ♥
- Excision, vaporization and hemostasis of abdominal tumors
- Excision, vaporization and hemostasis of rectal pathology
- Pilonidal cystectomy .
- Herniorapphy .
- Adhesiolysis �
- Parathyroidectomy
- Laparoscopic cholecystectomy
- Thyroidectomy
- Resection of organs
- Debridement of wounds �
- Phototcoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and ◆ extremities
- Endovascular coagulation of the greater saphenous vein of � the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities .
Urology
Excision, vaporization, incision, coagulation, ablation and homeostasis of urological tissues. Examples include:
- Vaporization of urethral tumors ●
- Release of urethral stricture .
- Removal of bladder neck obstruction
- Excision and vaporization of condyloma
- Lesions of external genitalia
Division Sign-Off) >ivision of General, Restorative,
ad Neurological Devices
4060326 10(k) Number.
5
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation .
- Excision or vaporization of condylomata acuminata .
Page 4 of
- Vaporization of cervical intraepithelial neoplasia 0
- Cervical conization .
- Menorrhagia .
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: homeostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture ◆
- Benign and malignant pulmonary obstruction
- Endoscopic pulmonary applications
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectory, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
Prescription Use X (Part 21 C.F.R. 801 Subpart D).
elmaee
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_ 406032 6