510(k) · Cleared
ClearedBeamax/ Formax Pulsed Light Device Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharplight Technologies, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Nov 10, 2008 as substantially equivalent to K050047 (Cutera, Inc., 2005) and 2 other predicates after a 42-day review. Its family tree reaches back 15 generations to 1995. 57 later devices descend from it.
- Decided
- Nov 10, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K943450 (1995). 241 ancestors in all, the oldest K800617 (1980). 57 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- Descendant · cites it directly · 56 of its ownK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- Descendant · 2 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 3 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 4 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
- Descendant · 5 generations on · 18 of its ownK153568 InMode Plus SystemInmode MD, Ltd. · 2016
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011 · cites it directly56descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 2 generations on33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 3 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · 4 generations on31descendants
- K153568InMode Plus SystemInmode MD, Ltd. · 2016 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| +1 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| +2 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +3 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +4 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| +5 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 11 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 30 | 0 |
| 2003 | 21 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K050047 | Cutera Optional Pulsed Light Hand Piece FamilySummary page 1…Regulation: 21 CFR § 878.4810 Regulatory Class: II Identification of Legally Marketed Predicate Devices Cutera Optional Pulsed Light Hand Piece Family - K050047 Alma - Harmony XL Multi-Application Platform - K072564 SharpLight - BEAMAX Pulse Light System - K063249 Device Descriptio… | 2005 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 1…II Identification of Legally Marketed Predicate Devices Cutera Optional Pulsed Light Hand Piece Family - K050047 Alma - Harmony XL Multi-Application Platform - K072564 SharpLight - BEAMAX Pulse Light System - K063249 Device Description The proposed BEAMAX/ FORMAX family system is a pulse… | 2008 |
| * | K063249 | BeamaxSummary page 1…Devices Cutera Optional Pulsed Light Hand Piece Family - K050047 Alma - Harmony XL Multi-Application Platform - K072564 SharpLight - BEAMAX Pulse Light System - K063249 Device Description The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlam… | 2007 |
What descends from it? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111303 | Dermatological Treatment Device Family | 2011 | 56 |
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 13 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 9 of the 241 ancestors have a recall of any class.
- Of its descendants, K111303 (Sharplight Technologies, Ltd., 2011) has gone furthest, with 56 descendants of its own.
- 4 other devices also cite its predicate K050047.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology. The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for: * Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair…
Read the full statement (161 words)
The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.
The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for:
* Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction.
- Recommended wavelengths in the range of 635-950 nm or 580-950 nm
* Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
* Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
* Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082876: Beamax/ Formax Pulsed Light Device Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082876
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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