Search Results
Found 6 results
510(k) Data Aggregation
K Number
K250195Device Name
MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
Manufacturer
Date Cleared
2025-05-30
(127 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MateLaser, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
**810 nm and 980 nm wavelength:**
MateLaser Medical Laser Therapy Systems (Model: ML HIL 30/60) emit energy in the invisible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
**980 nm wavelength:**
MateLaser Medical Laser Therapy Systems (Model: ML-HIL-60) are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
**980 nm wavelength:**
MateLaser Medical Laser Therapy Systems (Model: ML-HIL-60) are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K200693Device Name
K2 MOBILE
Manufacturer
Date Cleared
2020-11-19
(248 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
HULASER, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
K2 mobile laser is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows:
Endodontic procedures: Pulpotomy, Root canal therapy
Periodontal procedures: Sulcular debridement
Implant procedures: Implant recovery
Surgery procedures:
Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty
Other procedures:
Gingival troughing, Hemostasis and coagulation, Leukoplakia,
Treatment of aphthous-ulcer canker sores and herpetic,
Laser Assisted whitening,
Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle
Device Description
The dental diode laser (Model: K2 MOBILE) is a surgical device designed for a wide variety of dental soft tissue procedures. Diode laser is used as a source of invisible infrared radiation for this device and delivered to the treatment area through optical fiber is incorporated into a tip. The dental diode laser (Model: K2 MOBILE) is handpiece type using an internal rechargeable battery. The rechargeable battery charger are provided.
Ask a Question
Ask a specific question about this device
K Number
K170068Device Name
Softcure 96
Manufacturer
Date Cleared
2017-05-05
(116 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
WELLRAY MEDICAL LASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Softcure TM 96 is intended to emit energy in the visible spectrum (red 635mm) to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscular and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
Device Description
The Wellray® Medical Laser Softcure™ 96 is a therapeutic device using wavelengths of monochromatic light produced by semiconductor laser diodes to treat a variety of musculoskeletal concerns. The Softcure ™ 96 is a portable and wearable, battery powered, software controlled device intended for use on the body such as the back, legs, chest, arms or other areas where therapeutic light may be beneficial. A flexible pad, drawing power through an electrical cable from a carry able battery pack, emits red (635nm) light by means of semiconductor laser diodes to the desired body area. The flexible pad is designed to conform to the contour of the treatment site providing uniform treatment dosage over nonplanar body physique. The semiconductor laser diodes are monitored for temperature and light output by a microprocessor and cooled by variable speed fans to ensure the optimum light output. The lasers are allowed to energize only when four separate failsafe monitoring systems sense that the flexible pad is brought into close contact with the user's body. These failsafe systems include capacitive proximity sensors, body temperature sensors, an ambient light sensor and reference voltage monitoring.
Ask a Question
Ask a specific question about this device
K Number
K023060Device Name
ACCULASER PRO4
Manufacturer
Date Cleared
2004-03-19
(553 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ACCULASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Acculaser™ Pro4 is indicated for adjunctive use in providing temporary relief of pain associated with iliotibial band syndrome.
Device Description
The Acculaser™ Pro4 is a low level laser therapy device. It is non-thermal and emits infrared energy at 830 nm.
Ask a Question
Ask a specific question about this device
K Number
K020657Device Name
ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
Manufacturer
Date Cleared
2002-07-29
(151 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ACCULASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Acculaser Pro Low Level Laser Therapy Device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Device Description
The Acculaser Pro LLLT has a hand-held treatment probe, is non-thermal, and emits infrared energy at 830nm.
Ask a Question
Ask a specific question about this device
K Number
K983965Device Name
CO2 LASER COUPLER
Manufacturer
Date Cleared
1998-12-22
(46 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The coupler interfaces at the distal knuckle of the CO2 Laser and either the operating laparoscope or second puncture tubes allowing direct delivery of the focused beam.
Device Description
CO2 Laser Coupler
Ask a Question
Ask a specific question about this device
Page 1 of 1