510(k) · Cleared
ClearedV30 system, V-Form Handpiece BC Medium applicator
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 Nov 18, 2016 as substantially equivalent to K133837 (Viora, Ltd., 2014) and 2 other predicates after an 87-day review. Its family tree reaches back 21 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 18, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K943450 (1995). 313 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK142093 V20 SystemViora, Ltd. · 2014
- 2 generations backK150035 V10 systemViora, Ltd. · 2015
- 1 generation backK152611 V20 systemViora, Ltd. · 2016
- This deviceK162363 V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK202247 V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK201064 V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK200468 V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd. · 2020
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 8 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 7 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 6 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 5 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 4 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 3 generations backK142093 V20 SystemViora, Ltd. · 2014
- 2 generations backK150035 V10 systemViora, Ltd. · 2015
- 1 generation backK152611 V20 systemViora, Ltd. · 2016
- This deviceK162363 V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd. · 2020 · cites it directly0descendants
- K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd. · 2020 · cites it directly0descendants
- K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −8 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −7 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −6 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −5 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −4 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −3 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −2 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| −1 | K152611 | V20 system | Viora, Ltd. | 2016 | — |
| 0 (this device) | K162363 | V30 system, V-Form Handpiece BC Medium applicator | Viora, Ltd. | 2016 | — |
| +1 | K202247 | V30 system, V20 system, V10 system, V-VR Hand piece | Viora, Ltd. | 2020 | — |
| +1 | K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | Viora, Ltd. | 2020 | — |
| +1 | K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | Viora, Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K133837 | Viora V-TotalSummary page 5…878.4810, 21CFR878.4400 Class: II Panel: General and plastic surgery devices Predicate Viora V-total system (K133837) Device(s): Viora V20 system (K152611) Viora V10 system (K150035)… | 2014 |
| * | K152611 | V20 systemSummary page 5…ss: II Panel: General and plastic surgery devices Predicate Viora V-total system (K133837) Device(s): Viora V20 system (K152611) Viora V10 system (K150035)… | 2016 |
| * | K150035 | V10 systemSummary page 5…lastic surgery devices Predicate Viora V-total system (K133837) Device(s): Viora V20 system (K152611) Viora V10 system (K150035) 2 Device description The… | 2015 |
What descends from it? (3)
3 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 21 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 11 of the 313 ancestors have a recall of any class.
- Of its descendants, K202247 (Viora, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133837.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 V30 system is intended for dermatological procedures. The V-ST Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The V-IPL Handpiece with wavelengths 415-l200nm (with 5 different filters) is indicated for the treatment of: • Moderate inflammatory acne vulgaris. • Benign pigmented epidermal lesions including dyschromia…
Read the full statement (533 words)
The Viora V30 system is intended for dermatological procedures.
The V-ST Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The V-IPL Handpiece with wavelengths 415-l200nm (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 V-Nd:YAG 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 (0.1-4.0 mm 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-aulait 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 is 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).
The V-Form Handpiece (with BC Small, Medium and Large applicators) is indicated for delivering non thermal RF combined with massage:
• relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and
• temporary reduction in the appearance of cellulite.
The Viora V20 and V10 systems with V-Form Handpiece (with BC Small, Medium and Large applicators) are indicated for delivering non thermal RF combined with massage:
• relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and
• temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162363 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162363: V30 system, V-Form Handpiece BC Medium applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162363
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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