# K960032: Coherent Versapulse Aesthetic Surgical Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Coherent Medical Group
- Decided: Apr 1, 1996 after 90 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: 1 generation back to K904627 (1991). 16 ancestors in all.
1,152 later devices descend from it; 6 cite it directly.
0 of 1,169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941841: Smartscan, Laserscope (1994) Summary page 1.
- K933880: SL Series Surgical Laser Systems, Laserscope (1994) Summary page 1.
- K911830: Laserscope (R) KTP/532 and KTP/Yag Surgical Laser, Laserscope (1991) Summary page 1.
- K952636: Medlite Laser System, Continuum Biomedical, Inc. (1995) Summary page 1.
- K922935: Conbio-Medlite Q-Switched ND:Yag Laser System, Buckman Co., Inc. (1993) Summary page 1.
- K922577: Conbio-Medlite (TM) Q-Switched ND:Yag Laser System, Continuum Biomedical, Inc. (1993) Summary page 1.
- K935631: Conbio Medalex Laser System, Continuum Biomedical, Inc. (1994) Summary page 1.
- K944090: Candela Alex Lazr Q-Switched Alexandrite Laser, Candela Laser Corp. (1994) Summary page 1.
- K940173: Candela Q-Switched Alexandrite Laser, Candela Laser Corp. (1994) Summary page 1.
- K905802: Centauri/Pegasus, Pfizer Laser Systems (1991) Summary page 1.
- K904627: Centauri Yag Laser Syst, Ear, Nose , Throat, Pfizer Laser Systems (1991) Summary page 1.
- K933057: Multilite Erbium:Yag Surgical Laser System, Continuum Electro-Optics, Inc. (1994) Summary page 1.
- K950661: Candela 10MM Circular Spot Laser Handpiece, Candela Laser Corp. (1995) Summary page 1.
- K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 1.
- K946304: Coherent Family of CO2 Surgical Laser Scanner Handpieces, Lumenis, Inc. (1995) Summary page 1.
- K934486: Cool Laser Optics (Clo) Unit, Cyruschess (1994) Summary page 1.

## Most influential descendants
- K972347: Modified Coherent Versapulse Aesthetic Surgical Laser (1997), 1,142 descendants of its own
- 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

## Indications for use
The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.

Source page: https://510kreport.com/device/K960032
Methodology: https://510kreport.com/methodology