(95 days)
Not Found
No
The summary describes a laser device with various surgical and aesthetic applications. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The basis for substantial equivalence is comparison to predicate devices based on specifications and intended uses, not performance studies related to AI/ML.
Yes
The device is indicated for numerous medical treatments, including coagulation and hemostasis of vascular lesions, incision and excision of soft tissue, treatment of benign pigmented lesions, reduction of hypertrophic and keloid scars, and various surgical applications across multiple medical specialties. These are all therapeutic applications.
No
Explanation: The Adept 1064/755 Laser is indicated for various therapeutic and surgical applications such as coagulation, hemostasis, hair reduction, cutting, and ablation, rather than for diagnosing conditions.
No
The device description explicitly states it is a laser system combining different laser types (Nd: YAG and alexandrite lasers), which are hardware components. The intended use also describes procedures performed with a physical laser device.
Based on the provided text, the Adept 1064/755 Laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device that directly interacts with and treats human tissue (coagulation, hemostasis, removal of hair, incision, excision, etc.). IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system that emits energy at specific wavelengths to interact with tissue. This is consistent with a therapeutic or surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
The Adept 1064/755 Laser is a therapeutic laser system used for various medical and cosmetic procedures.
N/A
Intended Use / Indications for Use
The Adept 1064/755 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 1064/755 Laser is intended for:
755 nm wavelength
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/otorhinolarvngology (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 Adept 1064/755 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 Adept 1064/755 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 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 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 by-pass 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Adept 1064/755 Laser combines a long pulse Nd: YAG laser which emits energies at 1064 nm and 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
Not Found
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, K994260, K984601, K014040, K003202, K023954, K022226, K981798, K990903, K003765, K003147, K010284, K010834, K020021, K020697
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
OCT 2 4 2003
SECTION 9
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the Adept 1064/755 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.
- Adept Medical Concepts, Inc. Applicant: 29816 Avenue De Las Banderas Address: Rancho Santa Margarita, CA 92688 Mr. Jerry McFarland Contact person: President jmcfarland@adeptmedicalconcepts.com 949-635-9238 Telephone: 949-635-9106 (fax) Preparation Date: June 2003 (of the Summary) Adept 1064/755 Laser Device Name: Common Name: Surgical laser 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 Predicate devices: The Depilase Twin LASE Laser (K020412); Cynosure Apogee-TKS Laser (K992757); 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) and the and Depilase Twin YAG Laser (K020697). Device description: The Adept 1064/755 Laser combines a long pulse Nd: YAG laser which emits energies at 1064 nm and 532 nm and an alexandrite laser which emits energy at 755 nm.
1
- Indications: The Adept 1064/755 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 1064/755 Laser is intended for:
755 nm wavelength
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/otorhinolarvngology (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 Adept 1064/755 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 Adept 1064/755 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.
2
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 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 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.
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/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.
- 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 1064/755 Laser is substantially equivalent to the claimed predicate(s) - see listing above for the indications for use as listed.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
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: K032221 Trade/Device Name: Adept 1064/755 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 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.
5
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.
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Adept 1064/755 Laser
Indications for Use Statement:
The Adept 1064/755 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 1064/755 Laser is intended for:
755 nm wavelength
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 general surgery, gastroenterology, general surgery, gynecology, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology.
Mark - Millam
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number: K032221
lory
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
064
7
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 Adept 1064/755 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.
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 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 surgerv 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
lds.
Mark N. Millner
vision of General, Restorative and Neurological Devices
Number _
065
8
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, A VMs. 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 by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).
Mark M. Millkern
Division Sign-Off)
Division of General Restorative
and Neurological Devices
1/03222
9
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.
Mark A Millam
sion Sign-Off) ision of General, Rest rative and recurological Devices
Number K032221
40FY