510(k) · Cleared
ClearedViora V-Total
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viora, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Apr 9, 2014 as substantially equivalent to K090221 (Viora, Ltd., 2009) and 2 other predicates after a 112-day review. Its family tree reaches back 17 generations to 1995. 33 later devices descend from it.
- Decided
- Apr 9, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K943450 (1995). 309 ancestors in all, the oldest K800617 (1980). 33 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 2 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 1 generation backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- This deviceK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · cites it directly · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 2 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
- Descendant · 3 generations on · 18 of its ownK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- Descendant · 4 generations on · 13 of its ownK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- Descendant · 5 generations on · 8 of its ownK183450 EmBody SystemInmode MD, Ltd. · 2019
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 4 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 3 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 2 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 1 generation backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- This deviceK133837 Viora V-TotalViora, Ltd. · 2014
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K142093V20 SystemViora, Ltd. · 2014 · cites it directly32descendants
- K150035V10 systemViora, Ltd. · 2015 · 2 generations on31descendants
- K153568InMode Plus SystemInmode MD, Ltd. · 2016 · 3 generations on18descendants
- K172302InMode PLUS SystemInmode MD, Ltd. · 2017 · 4 generations on13descendants
- K183450EmBody SystemInmode MD, Ltd. · 2019 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −4 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −2 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −1 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| 0 (this device) | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +1 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +2 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| +3 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| +4 | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
| +5 | K183450 | EmBody System | Inmode MD, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 10 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 15 | 0 |
| 1995 | 15 | 0 |
| 1996 | 20 | 0 |
| 1997 | 23 | 0 |
| 1998 | 21 | 0 |
| 1999 | 12 | 0 |
| 2000 | 25 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 23 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K090221 | Reaction SystemSummary page 3…ence to the following predicate devices is claimed: Device Name -. 510k No Date of Clearance Viora Reaction System K090221 July 1, 2009 Alma Harmony XL K113810 March8,2012 OmniMax (Multi-Application… | 2009 |
| * | K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesSummary page 3…-. 510k No Date of Clearance Viora Reaction System K090221 July 1, 2009 Alma Harmony XL K113810 March8,2012 OmniMax (Multi-Application Dermatological Treatment KI111303 Dec 21,2011… | 2012 |
| * | K111303 | Dermatological Treatment Device FamilySummary page 3…th the Viora Reaction (1K090221) and 3 other applicators: Both Nd:YAG and iPL applicators are equivalent to the Alma Harmony XL (K(113810) and the Omnimax (K1 11303). All have the same clinical indication and use the same technology. (Handpiece and applicator in this submission h… | 2011 |
What descends from it? (33)
See all 332 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 19 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 11 of the 309 ancestors have a recall of any class.
- Of its descendants, K142093 (Viora, Ltd., 2014) has gone furthest, with 32 descendants of its own.
- 6 other devices also cite its predicate K090221.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Viora V-total 7™ is intended for dermatological procedures. The ST handpiece is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation. The IPL handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of: * Moderate inflammatory acne vulgaris. * Benign pigmented epidermal lesions including dyschromia, hyperpigmentation…
Read the full statement (430 words)
The Viora V-total 7™ is intended for dermatological procedures.
The ST handpiece is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
The IPL handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of:
* Moderate inflammatory acne vulgaris.
* Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
* Cutaneous lesions including warts, scars and striae.
* Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte and venous malformations.
* Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The Nd:YAG Laser handpiece with wavelength 1064 nm comes with 4 different applicator spot diameters: 2x4, 3.5, 5.5 and 9.5 mm. The three smaller spot sizes (2x4, 3.5, 5.5 mm) are intended for:
- Benign vascular lesions such as, but not limited to treatment of: port wine stains, hemangiomas, Warts, superficial and deep telangiectasias (venulectasias), reticular veins (0.1-4.0mm dia.) of the leg, rosacea, venus lake, leg veins, spider veins, poikiloderma of civatte and angiomas.
* Benign cutaneous lesions, such as, but not limited to: warts, scars, striae and psoriasis.
* Benign pigmented lesions such as, but not limited to: lentigos (age spots), solar lentigos (sun spots), cafe-au-lait macules, seborrheic keratosis, nevi and nevus of Ota, chloasma, verrucae, skin tags and keratosis.
- Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
* The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles and perioral wrinkles.
The handpiece with a spot size of 9.5 mm is also intended for treatment of: Laser skin resurfacing procedures for the treatment of: acne scars and wrinkles. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The handpiece with a spot size of 9.5 mm is also intended for removal of unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen and treatment of pseudofolliculitis barbae (PFB).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133837: Viora V-Total.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133837
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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