(90 days)
510(k)955734
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe any features or functionalities that would typically involve these technologies.
Yes
The device is intended for the "treatment of wrinkles/rhytides; solar/actinic elastosis; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors," indicating a therapeutic purpose.
No
The provided text describes the device's indications for treatment, not for diagnosing conditions. It mentions "soft tissue clearances previously obtained by Heraeus Surgical," implying a treatment rather than diagnostic role.
No
The device description explicitly lists hardware components: "ParaScan™ Scanning Device A." and "CBH-1 Collimated Beam Handpiece B."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for treating various soft tissue conditions and skin issues. IVDs are used for diagnosing diseases or conditions by examining samples (like blood, urine, tissue) in vitro (outside the body).
- Device Description: The description mentions a "Scanning Device" and a "Collimated Beam Handpiece," which are consistent with a device that delivers energy for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are therapeutic devices, not IVDs.
N/A
Intended Use / Indications for Use
The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO, soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkles/rhytides; solar/actinic elastosis; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
510(k)955734
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
964520 . FEB 10 1997
SUMMARY OF SAFETY AND EFFECTIVENESS PARASCAN SCANNING DEVICE OR CBH-1 COLLIMATED BEAM HANDPIECE FOR TREATMENT OF WRINKLES/RHYTIDES
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Lisa McGrath Sr. Regulatory Affairs Specialist Laserscope 3052 Orchard Parkway San Jose, CA 95134-2011 (408) 943-0636 (408) 943-1454 FAX
DEVICE TRADE NAME:
- ParaScan™ Scanning Device A.
- CBH-1 Collimated Beam Handpiece B.
DEVICE COMMON NAME:
- A. Scanning Laser Delivery System
- B. Collimated Handpiece
Heraeus Surgical, Inc., including the LaserSonics product line, was Note: acquired by Laserscope.
000004
1
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
DEVICE CLASSIFICATION:
CO, laser systems have been classified as Class II (79 GEX) medical devices by the OB/GYN. General, Plastic Surgery and ENT Device Advisory Panels. To the best of our knowledge, scanning laser delivery systems and handpiece accessories have not been classified.
PERFORMANCE STANDARDS:
The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.
INDICATIONS FOR USE STATEMENT:
The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO, soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkles/rhytides; solar/actinic elastosis; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.
000005
2
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3
. . .
COMPARISON WITH PREDICATE DEVICE:
The ParaScan Scanning Device was determined substantially equivalent by FDA on February 13, 1996 for all previously cleared LaserSonics CO, soft tissue surgical applications (510(k)955734). The CBH-1 Collimated Beam Handpiece is equivalent to the ParaScan Scanning Device beam collimator and handpiece.
000006