(69 days)
Not Found
Not Found
No
The document describes a diode laser system for various surgical procedures and does not mention any AI or ML capabilities.
Yes
The device is used for various medical procedures such as hemostasis, incision, excision, ablation, and vaporization of tissues across multiple anatomical sites for therapeutic purposes (e.g., removal of lesions, treatment of conditions, surgical interventions).
No
The provided text describes the device's intended use for various surgical procedures involving tissue alteration (e.g., hemostasis, incision, excision, ablation, vaporization), which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states "Aurora™ HL Diode Laser System," indicating a hardware component (a laser system). The intended uses also describe procedures involving tissue manipulation (hemostasis, incision, excision, ablation, vaporization), which are performed by a physical device, not software alone.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes surgical procedures performed directly on the patient's body (hemostasis, incision, excision, ablation, vaporization of tissues). IVDs are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health.
- Device Description: The device is a "Diode Laser System," which is a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for surgical intervention and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples:
- 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
- Pulpotomy and pulpotomy as an adjunct to root canal therapy .
- Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples:
- . Meniscectomy
- Synovectomy
- Chondromalacia .
GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples:
- Hemostasis of upper and lower GI bleeding .
- Excision and vaporization of colorectal carcinoma .
- Excision of polyps ●
GENERAL SURGERY, DERMATOLOGY & PLASTIC SURGERY, AND
PODIATRY: excision, ablation, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion. Examples:
- Matrixectomy .
- Excision of neuromas
- Excision of periungual & subungual warts ●
- Port wine stain removal
- Excision of plantar warts
- Excision of keloids
- Cholecystectomy
- Liver resection .
- Excision of cutaneous lesions ●
- Hemorrhoidectomy
- Appendectomy ●
- Debridement of decubitus ulcer ●
- Hepatobiliary ●
- Mastectomy ●
- Dermabrasion ●
- Vaporization & hemostasis of capillary hemangioma ●
- Excision, vaporization & hemostasis of abdominal tumors .
- Excision, vaporization & hemostasis or rectal pathology .
- Pilondial cystectomy ●
- Herniorrhaphy .
- . Adhesiolysis
- Parathyroidectomy ●
- Laparoscopic cholecystectomy .
- Thyroidectomy .
- Resection of organs ●
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples:
- Hemorrhoidectomy .
- Excision, vaporization and hemostasis of rectal pathology .
- Excision, vaporization, and hemostasis of abdominal tumors .
GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue. Examples:
- Endometrial ablation .
- Excision or vaporization of condylomata acuminata ●
- Vaporization of CIN (cervical intraepithelelial neoplasis) .
- Cervical conization ●
- Menorrhagia .
NEUROSURGERY:
-
Hemostasis ◆
: -
Hemostasis for myangioma ●
OPHTHALMOLOGY: -
Incision, excision and vaporization of tissue surrounding the eye and orbit
-
Photocoagulation of the retina ●
PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue. Examples:
- Tracheobronchial malignancy or stricture .
- Benign and malignant pulmonary obstruction .
UROLOGY: Hemostasis, vaporization and excision of tissues. Examples:
- Vaporization of urethral tumors .
- Release of urethral stricture ●
- Removal of bladder neck obstruction .
- Excision and vaporization of condyloma .
- Lesions of external genitalia .
Product codes (comma separated list FDA assigned to the subject device)
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, throat, oral cavity, joint tissues, upper and lower gastrointestinal tracts, skin, abdominal, rectal, fat, muscle tissues, cervical, retinal, tracheobronchial, urethral, 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)
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.
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1999
Ms. Beth A. Roberts Regulatory Specialist Premier Laser Systems 3 Morgan Irvine, California 92618
Re: K992374
Trade Name: Aurora™ HL Diode Laser System Regulatory Class: II Product Code: GEX Dated: July 7, 1999 Received: July 15, 1999
Dear Ms. Roberts:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Ms. Beth A. Roberts
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
to coelle
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page __ 1 of _3
510(k) Number (if known): K992374
Device Name: Aurora™ HL Diode Laser System
Indications for Use:
EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples:
- 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 �
- Pulpotomy and pulpotomy as an adjunct to root canal therapy .
- Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples:
- . Meniscectomy
- Synovectomy
- Chondromalacia .
GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples:
- Hemostasis of upper and lower GI bleeding .
- Excision and vaporization of colorectal carcinoma .
- Excision of polyps ●
GENERAL SURGERY, DERMATOLOGY & PLASTIC SURGERY, AND
PODIATRY: excision, ablation, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion. Examples:
- Matrixectomy .
- Excision of neuromas �
- Excision of periungual & subungual warts ●
- Port wine stain removal �
- Excision of plantar warts �
- Excision of keloids
- Cholecystectomy �
- Liver resection .
- Excision of cutaneous lesions ●
- Hemorrhoidectomy
Prescription Use (Per 21 CFR 801.109)
(Division Sian Off Division of General Restorative D 510(k) Number
3
- Appendectomy ●
- Debridement of decubitus ulcer ●
- Hepatobiliary ●
- Mastectomy ●
- Dermabrasion ●
- Vaporization & hemostasis of capillary hemangioma ●
- Excision, vaporization & hemostasis of abdominal tumors .
- Excision, vaporization & hemostasis or rectal pathology .
- Pilondial cystectomy ●
- Herniorrhaphy .
- . Adhesiolysis
- Parathyroidectomy ●
- Laparoscopic cholecystectomy .
- Thyroidectomy .
- Resection of organs ●
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples:
- Hemorrhoidectomy .
- Excision, vaporization and hemostasis of rectal pathology .
- Excision, vaporization, and hemostasis of abdominal tumors .
GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue. Examples:
- Endometrial ablation .
- Excision or vaporization of condylomata acuminata ●
- Vaporization of CIN (cervical intraepithelelial neoplasis) .
- Cervical conization ●
- Menorrhagia .
NEUROSURGERY:
-
Hemostasis ◆
: -
Hemostasis for myangioma ●
OPHTHALMOLOGY:
- Incision, excision and vaporization of tissue surrounding the eye and orbit �
- Photocoagulation of the retina ●
PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue. Examples:
- Tracheobronchial malignancy or stricture .
- Benign and malignant pulmonary obstruction .
UROLOGY: Hemostasis, vaporization and excision of tissues. Examples:
- Vaporization of urethral tumors .
- Release of urethral stricture ●
- Removal of bladder neck obstruction .
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Seneral Restorative De 510(k) Number
4
- Excision and vaporization of condyloma .
- Lesions of external genitalia .
NOTE:
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
bcsefo
(Division Sign-Off) Division of General Restorative Devices 510(k) Number .
Prescription Use X (Per 21 CFR 801.109)
Or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
923