(95 days)
Not Found
No
The summary describes a laser device with different wavelengths for various medical procedures. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies section explicitly states that none were required and substantial equivalence is based on specifications and intended uses, which is typical for non-AI/ML devices.
Yes
This device is indicated for a wide range of medical treatments including coagulation, hemostasis, incision, excision, vaporization, and ablation of various tissues for conditions and procedures across multiple medical specialties, which are considered therapeutic applications.
No
The device is a therapeutic laser used for various medical and cosmetic procedures like coagulation, hemostasis, hair reduction, and tissue ablation. It is used for active treatment, not for diagnosing conditions.
No
The device description explicitly states it is a laser system combining different laser types (Nd: YAG, KTP crystal, alexandrite laser) which are hardware components. The intended use also describes procedures performed by a physical laser device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Adept 1064/532/755 Laser is a laser system that directly interacts with the patient's body for therapeutic and cosmetic purposes (coagulation, hemostasis, hair removal, tissue ablation, etc.). It does not analyze samples taken from the body.
- Intended Use: The stated intended uses clearly describe procedures performed on the patient, not tests performed on samples from the patient.
Therefore, the Adept 1064/532/755 Laser falls under the category of a therapeutic or surgical medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Adept 1064/532/755 Laser is indicated for coagulation and hemostasis of vascular lesions and removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
755 nm wavelength:
For the coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.
1064 nm wavelength:
General Surgical Applications: For the incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.
Dermatology/Plastic Surgery: For photocoagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the 1064/532/755 Laser is intended for the treatment of benign, pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots). café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of blue and/or black tattoos) and plaques. The 1064/532/755 Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Cutting, incision, excision, hemostasis, coagulation, vaporization, and ablation of soft tissue in dermatology and plastic surgery. For the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. For the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). For the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. For use on all skin types (Fitzpatrick I - IV) including tanned skin. and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types (1064 nm wavelength).
Endoscopic/Laparoscopic Surgery: For use in a variety of surgical procedures in several surgical specialties. These include, but are not limited to, cholecystectomy, appendectomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.
General Surgery: For incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.
Gynecology: For the treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.
Head and Neck/-Otorhinolaryngology (ENT): For tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis During Surgery: For adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.
Neurosurgery: For hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.
Oculoplastics: For incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents.
Pulmonary Surgery: For palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.
Thoracic Surgery: For cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectomy and/or bypass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).
Urology: For all applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).
Orthopedics: For cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.
532 nm wavelength:
For the coagulation and hemostasis of vascular lesions.
Dermatology/Plastic Surgery: For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins]: benign pigmented lesions (nevi, lentigines, chloasma, café au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size.
General Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft Tissue as well as in Endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Esophagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric Erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Head and Neck Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis during Surgery: Adiunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery.
Neurosurgery: Hemostasis for: Pituitary Tumor, Meningioma; hemagioblastoma; AVMs; Glioma; Glioblastoma: Astrocytoma: Oligodendroglioma.
Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.
Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary a airway obstructions, including Squamous Cell Carcinoma, Adenocarcinoma, Carcinoid; Benign Tumors; Granulomas; Benign Strictures.
Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporizing of soft tissue. Thoracic applications including, but not limited to: Isolation of vessels for endartecetomy and/or by-pass grafts, Wedge Resections, Thoractomy, Formation of Pacemaker pockets. Vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (Thoracoscopy).
Urology: All applications including: Superficial urinary bladder tumors, invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).
Product codes
GEX
Device Description
The Adept 1064/532/755 Laser combines a long pulse Nd: Y AG laser which emits energies at 1064 nm with a KTP crystal which converts the 1064 nm laser to 532 nm and an alexandrite laser which emits energy at 755 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, soft tissue, vascular lesions, hair follicles, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos, plaques, hypertrophic and keloid scars, facial wrinkles, periocular and periorbital wrinkles, female reproductive organs (uterus, endometrial implants, peritoneal adhesions, cervix, fibroids, endometrial polyps, uterine septum), gastrointestinal tract (esophagus, stomach, colon, hemorrhoids), head and neck, pituitary tumor, meningioma, hemagioblastoma, AVMs, glioblastoma, astrocytoma, oligodendroglioma, lacrimal system, eyelids, orbital tumors, eyeball, orbital contents, pulmonary airway obstructions, lung tissue, vessels for endarterectomy and/or by-pass grafts, pacemaker pockets, urinary bladder, urethra, external genitalia, intra-articular tissue, retina.
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)
None required. The claim of substantial equivalence is based on comparisons of specifications/characteristics and intended uses of the claimed predicate.
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.
K020412, K992757, K020697, K994260, K984601, K014040, K003202, K023954, K022226, K981798, K990903, K003765, K003147, K010284, K010834, K020021
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
K 032218 1/6
SECTION 9
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the Adept 1064/532/755 Laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
- Applicant: Adept Medical Concepts, Inc.
- 29816 Avenue De Las Banderas Address: Rancho Santa Margarita, CA 92688
- Contact person: Mr. Jerry McFarland President jmcfarland(@adeptmedicalconcepts.com
- 949-635-9238 Telephone: 949-635-9106 (fax)
Preparation Date: July 2003 (of the Summary)
-
Adept 1064/532/755 Laser Device Name:
Surgical laser Common Name: -
Classification: Laser surgical instrument for use in general and plastic surgery and dermatology
Class II medical device; (21 CFR 878.4810).
Product Code: GEX Panel: 79
- The Depilase Twin LASE Laser (K020412) and Depilase Twin YAG Laser Predicate devices: Cynosure Apogee-TKS Laser (K992757); (K020697); Candela GentleLASE GL (K994260) and GentleLASE II (K984601); Altus Family CoolGlide Aesthetic Lasers (K014040, K003202, K023954, K022226, K981798); and the Lyra Series Surgical Laser System (K990903, K003765, K003147, K010284, K010834, K020021).
- Device description: The Adept 1064/532/755 Laser combines a long pulse Nd: Y AG laser which emits energies at 1064 nm with a KTP crystal which converts the 1064 nm laser to 532 nm and an alexandrite laser which emits energy at 755 nm.
1
KO32218
Image /page/1/Picture/1 description: The image shows a fraction. The numerator is 2 and the denominator is 6. The fraction is written in a simple, handwritten style. The numbers are clear and easy to read.
- Indications: The Adept 1064/532/755 Laser is indicated for coagulation and hemostasis of vascular lesions and removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
The Adept 1064/532/755 Laser is intended:
755 nm wavelength
For the coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.
1064 nm wavelength
General Surgical Applications:
For the incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins. In addition, the 1064/532/755 Laser is intended for the treatment of benign, pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots). café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of blue and/or black tattoos) and plaques.
The 1064/532/755 Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Cutting, incision, excision, hemostasis, coagulation, vaporization, and ablation of soft tissue in dermatology and plastic surgery.
For the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.
For the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
2
For the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
For the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.
Endoscopic/Laparoscopic Surgery:
For use in a variety of surgical procedures in several surgical specialties. These include, but are not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.
General Surgery:
For incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.
Gynecology:
For the treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.
Head and Neck/Otorhinolaryngology (ENT):
For tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis During Surgery:
For adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.
Neurosurgery:
For hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.
3
Oculoplastics:
For incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents.
Pulmonary Surgery:
For palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.
Thoracic Surgery:
For cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision, debulking, and ablation of lung tissue (thoracoscopy).
Urology:
For all applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).
Orthopedics:
For cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.
532 nm wavelength
For the coagulation and hemostasis of vascular lesions.
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins]: benign pigmented lesions (nevi, lentigines, chloasma, café au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size.
4
Image /page/4/Picture/0 description: The image shows handwritten text on a white background. The text "KO32218" is written on the top line, and "5/6" is written on the bottom line. The numbers and letters are written in a simple, clear font.
General Surgery:
Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft Tissue as well as in Endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric Erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Head and Neck/Otorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis during Surgery:
Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery.
Neurosurgery:
Hemostasis for: Pituitary Tumor, Meningioma; hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.
Ophthalmology:
Post-vitrectomy endophotocoagulation of the retina.
Pulmonary Surgery:
Palliative treatment of benign and malignant pulmonary airway obstructions, including Squamous Cell Carcinoma, Adenocarcinoma, Carcinoid; Benign Tumors; Granulomas; Benign Strictures.
Thoracic Surgery:
Cutting (incision/excision), coagulating, and vaporizing of soft tissue. Thoracic applications including, but not limited to: Isolation of vessels for endartecetomy and/or by-pass grafts. Wedge Resections, Thoractomy, Formation of Pacemaker pockets. Vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (Thoracoscopy).
5
Image /page/5/Picture/0 description: The image shows handwritten text on a white background. The text "K032218" is on the top line, and "6/6" is on the bottom line. The handwriting is in black ink and appears to be cursive.
Urology:
All applications including: Superficial urinary bladder tumors, invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).
- Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications/characteristics and intended uses of the claimed predicate.
- Conclusion: Based on the information in the notification Adept Medical Concepts, Inc., believes that the Adept 1064/532/755 Laser is substantially equivalent to the claimed predicate(s) - see listing above.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle faces left and is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2003
Mr. Jerry McFarland President Adept Medical Concepts, Inc. 29816 Avenue De Las Banderas Rancho Santa Margarita, California 92688
Re: K032218
Trade/Device Name: Adept 1064/532/755 Laser 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: July 17, 2003 Received: August 4, 2003
Dear Mr. McFarland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
7
Page 2 - Mr. Jerry McFarland
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
SECTION 7
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K032218 |
|---|---|
| --------------------------- | --------- |
Device Name: Adept 1064/532/755 Laser
Indications for Use Statement:
The Adept 1064/532/755 Laser is indicated for coagulation and hemostasis of vascular lesions and removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
755 nm wavelength
For the coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.
1064 nm wavelength
General Surgical Applications:
For the incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider In addition, the 1064/532/755 Laser is intended for the treatment of benign, veins. pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots). café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of blue and/or black tattoos) and plaques.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR Over-T
miriam C. Provost
(Review Sign Off)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Over-The Counter Use ________________________________________________________________________________________________________________________________________________________
066
510(k) Number K032218
9
The 1064/532/755 Laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Cutting, incision, excision, hemostasis, coagulation, vaporization, and ablation of soft tissue in dermatology and plastic surgery.
For the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.
For the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
For the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
For use on all skin types (Fitzpatrick I - IV) including tanned skin. and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types (1064 nm wavelength).
Endoscopic/Laparoscopic Surgery:
For use in a variety of surgical procedures in several surgical specialties. These include, but are not limited to, cholecystectomy, appendectomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied.
General Surgery:
For incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids.
Gynecology:
For the treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine gynecologic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum.
Head and Neck/-Otorhinolaryngology (ENT):
For tissue incision, excision, ablation, and vessel hemostasis.
10
Hemostasis During Surgery:
For adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.
Neurosurgery:
For hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma.
Oculoplastics:
For incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents.
Pulmonary Surgery:
For palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.
Thoracic Surgery:
For cutting (incision/excision), coagulating, and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectomy and/or bypass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).
Urology:
For all applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminata).
Orthopedics:
For cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.
532 nm wavelength
For the coagulation and hemostasis of vascular lesions.
11
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins]: benign pigmented lesions (nevi, lentigines, chloasma, café au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size.
4/ 5
General Surgery:
Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft Tissue as well as in Endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Esophagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric Erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Head and Neck Otorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis during Surgery:
Adiunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery.
Neurosurgery:
Hemostasis for: Pituitary Tumor, Meningioma; hemagioblastoma; AVMs; Glioma; Glioblastoma: Astrocytoma: Oligodendroglioma.
Ophthalmology:
Post-vitrectomy endophotocoagulation of the retina.
Pulmonary Surgery:
Palliative treatment of benign and malignant pulmonary a airway obstructions, including Squamous Cell Carcinoma, Adenocarcinoma, Carcinoid; Benign Tumors; Granulomas; Benign Strictures.
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K032218 2/5
Thoracic Surgery:
Cutting (incision/excision), coagulating, and vaporizing of soft tissue. Thoracic applications including, but not limited to: Isolation of vessels for endartecetomy and/or by-pass grafts, Wedge Resections, Thoractomy, Formation of Pacemaker pockets. Vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (Thoracoscopy).
Urology:
All applications including: Superficial urinary bladder tumors, invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).