# K972347: Modified Coherent Versapulse Aesthetic Surgical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Sep 19, 1997 after 87 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904627 (1991). 19 ancestors in all.
1,142 later devices descend from it; 3 cite it directly.
0 of 1,162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960032: Coherent Versapulse Aesthetic Surgical Lasers, Coherent Medical Group (1996) Summary page 1.
- K944090: Candela Alex Lazr Q-Switched Alexandrite Laser, Candela Laser Corp. (1994) Summary page 1.
- K961748: Medlite/Erbium Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.

## Most influential descendants
- K001589: Candela Dynamic Cooling Device (2000), 1,064 descendants of its own
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), 1,046 descendants of its own
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems (2003), 856 descendants of its own
- K030342: Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems (2003), 756 descendants of its own
- K024093: Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and ND:Yag Laser Systems (2003), 756 descendants of its own

## Indications for use
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 tattoos (yellow, green, red), treatment of cutaneous lesions including colored vascular lesions (i.e., port wine hemangiomas/stains - PWS), pigmented lesions and other cutaneous 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.) - telangiectasia Benign pigmented lesions - 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 tattoos (blue-black tattoos), 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:YAG 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.

Source page: https://510kreport.com/device/K972347
Methodology: https://510kreport.com/methodology