(87 days)
The modified Coherent VersaPulse Aesthetic Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation, or coagulation) of soft tissue in medical specialties including: dermatology; plastic surgery; and general surgery as follows:
a. Laser Wavelengths
- 532 nm: Non-Q-switched pulsed and Q-Switched modes - Indicated for the removal of light colored tattops (yellow, green, red), treatment of cutaneous lesions including colored vascular lies., port wirini hemangiomas/ stains - PWS), pigmented les lesions - these indications include: The treatment (hemostasis, color lightening, blanching, flattening and reduction of lesion size) of the following general categories of lesions: Vascular lesions (angiomas, hemangiomas (port wine h., cavernous h., cherry h., spider h.), telangièctasia), Benign pigmented lesions (nevi, lentigines (senile and solar), chloasma, cafe-au-lait (macules), tattoos), Other pigmented cutaneous lesions (verrucae, skin tags, keratoses, plaques);
- 1064 nm: Indicated for the removal of dark colored tatoos (blue-black tatoos), the treatment of cutaneous lesions, including colored vascular lesions (port wine hemangiomas / stains - PWS), and the treatment of pigmented lesions;
- 755 nm: Indicated for the treatment of pigmented lesions (e.g., epidermal and dermal lesions, including Nevus of Ota/Ito) and of multicolored tattoos, such as black, blue, green and other colors;
- 2940 nm: Indicated for use in surgical applications requiring excision, incision, ablation, vaporization and coagulation of soft tissue using laser energy emitted by Er: Y AG in general and plastic surgery and dermatology.
b. Epidermal Chiller Tip Accessory (Only for Use with 532 nm Wavelength)
The Epidermal Chiller Tip accessory, is intended for use only with the 532 nm wavelength, for use in cooling or chilling the epidermis of the treatment site both prior to and during laser treatment to minimize thermal injury to nonvascular structures during laser treatment of telangiectases and other vascular lesions (i.e., port wine stains), to protect the epidermis from thermal necrosis (thus reducing possible complications such as scabbing, scarring, and/or hyperpigmentation), and to minimize the discomfort or degree of pain experienced by the patient during laser treatment due to partial anesthesia from cooling, in dermatology and plastic surgery.
The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used to deliver: frequency doubled, Q-switched frequency doubled, and Q-switched Nd:YAG; Q-switched Alexandrite:YAG laser energy for use in surgical applications requiring the photothermolysis (photocoagulation) of soft tissue; and Er:YAG laser energy for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology. Coherent VersaPulse Aesthetic Surgical Lasers are comprised of the following main components: a laser console and tower; a counterbalanced articulated arm and delivery systems; a fiber port and delivery systems; control and display panels; footswitch and handswitch delivery controls; a remote control unit; and a variety of delivery device accessories (articulated arm and fiber handpieces, scanners, and epidermal cooling devices).
This 510(k) premarket notification for the Modified Coherent VersaPulse Aesthetic Surgical Lasers and Delivery Accessories does not contain acceptance criteria or a study proving device performance against such criteria.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their new device is as safe and effective as a legally marketed device that existed before May 28, 1976 (the Medical Device Amendments Act) or has been reclassified.
Here's why the requested information cannot be provided from this document:
- No Performance Data Submitted: Section VII explicitly states, "No performance data was submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based upon the comparison of the technical characteristics between the modified Coherent VersaPulse Aesthetic Surgical Lasers and the predicate laser systems and accessories."
- Focus on Substantial Equivalence: The entire rationale (Section VI and VIII) centers on comparing the new device's design features, functional features, and indications for use to those of predicate devices, not on demonstrating new performance through a study.
Therefore, for each of your requested points, the answer derived from this document is:
- A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data were submitted or reported.
- Sample size used for the test set and the data provenance: Not applicable. No test set was used, as no performance study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment was used.
- Adjudication method for the test set: Not applicable. No test set was used.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical laser, not an AI-assisted diagnostic tool. No such study was conducted or is relevant here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical laser, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established as no performance study was conducted.
- The sample size for the training set: Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth for it was established.
In summary, this 510(k) submission successfully achieved FDA clearance based on demonstrating substantial equivalence to existing, legally marketed surgical lasers. It did not involve a study with acceptance criteria or performance data as it was not required for this type of submission for this particular device.
§ 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.