(154 days)
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No
The summary describes a laser device for hair removal with no mention of AI or ML capabilities in its operation, intended use, or performance studies.
No.
The device is intended for hair removal, which is typically considered a cosmetic procedure rather than a therapeutic treatment for a disease or condition.
No
The device is described as a hair removal laser within dermatology and plastic surgery, and its intended use is to remove hair, not to diagnose a condition.
No
The device description clearly describes a physical laser system with hardware components like an articulated arm and a water-cooled handpiece, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal on patients with skin types 1-4 through photothermolysis of hair follicles. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser that delivers energy to the skin. This is a physical intervention, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
This device clearly falls under the category of a therapeutic medical device used for a cosmetic/dermatological procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Epilaser™ Normal Mode Ruby Laser is intended for hair removal of patients with skin types 1 - 4 through selective photothermolysis of hair follicles in dermatology and plastic surgery. This results in a prolonged growth delay.
Product codes
GEX
Device Description
The Epilaser" Normal Mode Ruby Laser operates at 694.3 nanometers with pulse durations of 0.2 - 3.0 msec. The delivered energy is directed to the treatment site by an articulated arm. A water-cooled handpiece (7 mm or 10 mm) is firmly held against the skin for 2-3 seconds and the laser is then fired. The Epilaser Normal Mode Ruby Laser is capable of producing energy fluences of 10-75 J/cm2.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Animal and clinical studies were conducted to provide assurance that differences in the specifications of the Epilaser™ Normal Mode Ruby Laser and the claimed predicate device for hair removal did not result in different performance during use.
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Animal Studies: Biopsies of control skin showed no alterations in the follicular epithelium or dermal collagen. Examination of irradiated skin showed damage to the follicular epithelium. Focal collagen damage occurred in reticular dermis immediately adjacent to the hair follicle. Observed effects increased with fluence levels.
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Clinical Studies: Observations in an initial study were recorded prior to treatment and at 1, 3 and 6-months after treatment. There was no scarring in any subject. The initial study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal, resulting in a prolonged growth delay. Subsequent studies, including patients treated for facial hair, confirmed the results of the initial study.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
MAR - 5 1997
ATTACHMENT I (Rev. 12/96)
510(K) SUMMARY
Bpilaser™ Normal Mode Ruby Laser
This 510(k) Summary of safety and effectiveness for the Epilaser™ Normal Mode Ruby Laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of 510 (k) a summary.
45 Hartwell Avenue
Technologies, Inc.
617-676-7330 (Fax)
December 26, 1996
Lexington, MA
617-676-7300
Ruby Laser
( K955612 )
(K950019)
Mr. Sanford Lane
Applicant :
- 1
Address :
Contact Person:
Telephone :
Preparation Date: (of the Revised Summary)
Epilaser™ Normal Mode Ruby Laser
President, Spectrum Medical
Spectrum Medical Technologies, Inc.
02173
Common Name:
Classification Name:
Device Trade Name:
Laser surgical instrument for use in general and plastic surgery and in dermatology (see 21 CFR 878-4810) Product Code: ઉંઝર્ Panel: 79
Epilaser™ Normal Mode Ruby Laser
Thermolase LT-100 Nd:YAG Laser
Legally Marketed Predicate Device(s):
Description of the Device:
The Epilaser" Normal Mode Ruby Laser operates 694.3 at nanometers with pulse durations of 0.2 - 3.0 msec. uhe delivered energy 18 to the treatment site by an articulated arm. A water-cooled handpiece (7 mm or 10 mm) is firmly held against the skin for 2-3 seconds and the laser is then fired.
1
The Bpilaser Normal Mode Ruby Laser is capable of producing energy fluences of 10-75 J/cm4.
- The Epilaser" Normal Mode Ruby Laser is Intended Use: to hair removal intended effect of patients with skin types 1 - 4 through photothermolysis hair selective of in dermatology and plastic follicles surgery. This results in a prolonged growth delay.
- The Epilaser" Normal Mode Ruby Laser for Comparison : hair removal has the same technological characteristics as the predicate Epilaser (1955612) . It differs from the Thermolase LT-100 Nd:YAG Laser predicate device (K950019) in that the Thermolase applies laser energy at 1064 nanometers in 10 nsec pulses onto a cream containing carbon. The devices operate by selective photothermolysis.
- Performance Data: Animal and clinical studies were conducted to provide assurance that differences in the specifications of the Epilaser™ Normal Mode Ruby Laser and the claimed predicate device for hair removal did not result in different performance during use.
- Animal Studies: Biopsies of control skin showed no alterations the follicular epithelium or dermal collagen. Examination of irradiated skin showed damage to the follicular epithelium. Focal collagen reticular dermas occurred damage in immediately adjacent to the hair follicle.
Observed effects increased with fluence levels.
- Clinical Studies: Observations in an initial study were recorded prior to treatment and at 1, ా and 6-months after treatment. There was no scarring in any subject.
The initial study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal, resulting in a prolonged growth delay.
2
2
Subsequent studies, including patients
treated for facial hair, confirmed the results of the initial study.
CONCLUSION : on the foregoing, the Epilaser" Based Normal Mode Ruby Laser is substantially equivalent to legally marketed claimed
predicate devices, i.e., the Bpilaser™ for dermatology and plastic surgery and the Thermolase LT-100 Nd:YAG laser for hair removal.