510(k) · Cleared
ClearedModified Coherent Versapulse Aesthetic Surgical Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 19, 1997 as substantially equivalent to K960032 (Coherent Medical Group, 1996) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1991. 1,142 later devices descend from it.
- Decided
- Sep 19, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K904627 (1991). 19 ancestors in all. 1,142 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 1 generation backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- This deviceK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
- Descendant · cites it directly · 1,064 of its ownK001589 Candela Dynamic Cooling DeviceCandela Corp. · 2000
- Descendant · 2 generations on · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- Descendant · 3 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
- Descendant · 3 generations on · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled
- Descendant · 3 generations on · 756 of its ownK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
Showing 5 of 1,142 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,142 · See all- K001589Candela Dynamic Cooling DeviceCandela Corp. · 2000 · cites it directly1,064descendants
- K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · 2 generations on1,046descendants
- K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 3 generations on856descendants
- K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · 3 generations on756descendants
- K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd. · 2003 · 3 generations on756descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −1 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| 0 (this device) | K972347 | Modified Coherent Versapulse Aesthetic Surgical Laser | Lumenis, Inc. | 1997 | — |
| +1 | K001589 | Candela Dynamic Cooling Device | Candela Corp. | 2000 | — |
| +2 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| +3 | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | Lumenis | 2003 | — |
| +3 | K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems | Lumenis, Ltd. | 2003 | 1 |
| +3 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 21 | 0 |
| 2006 | 24 | 0 |
| 2007 | 27 | 0 |
| 2008 | 44 | 0 |
| 2009 | 29 | 0 |
| 2010 | 30 | 0 |
| 2011 | 31 | 0 |
| 2012 | 28 | 0 |
| 2013 | 39 | 0 |
| 2014 | 41 | 0 |
| 2015 | 44 | 0 |
| 2016 | 54 | 0 |
| 2017 | 56 | 0 |
| 2018 | 47 | 0 |
| 2019 | 41 | 0 |
| 2020 | 55 | 0 |
| 2021 | 50 | 0 |
| 2022 | 82 | 0 |
| 2023 | 67 | 0 |
| 2024 | 94 | 0 |
| 2025 | 128 | 0 |
| 2026 | 77 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960032 | Coherent Versapulse Aesthetic Surgical LasersSummary page 1…y Classification Name: Laser Powered Surgical Instrument (and Accessories). Predicate Devices e Coherent VersaPulse Aesthetic Surgical Lasers and Delivery Accessories (K960032) e Candela ALEXLAZR (TL-1) Alexandrite Laser (K944090) * Continuum Biomedical Medlite/Erbium 2.94 Surgical Laser (K961748) Pro… | 1996 |
| * | K944090 | Candela Alex Lazr Q-Switched Alexandrite LaserSummary page 1…t (and Accessories). Predicate Devices e Coherent VersaPulse Aesthetic Surgical Lasers and Delivery Accessories (K960032) e Candela ALEXLAZR (TL-1) Alexandrite Laser (K944090) * Continuum Biomedical Medlite/Erbium 2.94 Surgical Laser (K961748) Product Description The Coherent VersaPulse Aesthetic Sur… | 1994 |
| * | K961748 | Medlite/Erbium Laser SystemSummary page 1…tic Surgical Lasers and Delivery Accessories (K960032) e Candela ALEXLAZR (TL-1) Alexandrite Laser (K944090) * Continuum Biomedical Medlite/Erbium 2.94 Surgical Laser (K961748) Product Description The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used t… | 1996 |
What descends from it? (1,142)
See all 1,1423 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K001589 (Candela Corp., 2000) has gone furthest, with 1,064 descendants of its own.
- 5 other devices also cite its predicate K960032.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (366 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972347: Modified Coherent Versapulse Aesthetic Surgical Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972347
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026