510(k) · Cleared
ClearedSculpture 2.94 ER:Yag System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoya Conbio, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Aug 27, 2008 as substantially equivalent to K970934 (Continuum Biomedical, Inc., 1997) and 7 other predicates after a 293-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Aug 27, 2008
- Review
- 293 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 14 generations to K943450 (1995). 374 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
- 1 generation backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- This deviceK073158 Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc. · 2008
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
- 1 generation backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- This deviceK073158 Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K053616 | Polaris WR, ST Applicator | Syneron Medical, Ltd. | 2006 | — |
| −1 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| 0 (this device) | K073158 | Sculpture 2.94 ER:Yag System | Hoya Conbio, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 7 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 23 | 0 |
| 1995 | 18 | 0 |
| 1996 | 27 | 0 |
| 1997 | 28 | 0 |
| 1998 | 26 | 0 |
| 1999 | 22 | 0 |
| 2000 | 30 | 0 |
| 2001 | 30 | 0 |
| 2002 | 38 | 0 |
| 2003 | 36 | 0 |
| 2004 | 18 | 0 |
| 2005 | 13 | 0 |
| 2006 | 7 | 0 |
| 2007 | 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? (9)
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 |
|---|---|---|---|
| * | K970934 | CB Erbium/2.94(TM) ER:Yag LaserSummary page 1…troy or coagulate tissue by light energy emitted by argon. Predicate (Equivalent) CB Erbium 2.94 (K970934) Device: VersaWave Dental Laser System (K041710O)… | 1997 |
| * | K041710 | Versawave Dental ER:Yag Laser SystemSummary page 1…emitted by argon. Predicate (Equivalent) CB Erbium 2.94 (K970934) Device: VersaWave Dental Laser System (K041710O) Multilite Erbium:YAG Surgical Laser System (K(933057)… | 2004 |
| * | K933057 | Multilite Erbium:Yag Surgical Laser SystemSummary page 2…configuration: CB Erbium 2.94 (K970934), the VersaWave Dental Laser System (K041710) and the Multilite Erbium:YAG Surgical Laser System (K933057) Indications: Fidelis XS (K990243), Multilite Erbium:YAG… | 1994 |
| * | K990243 | Fotona Fidelis ER:Yag Laser System & AccessoriesSummary page 1…K041710O) Multilite Erbium:YAG Surgical Laser System (K(933057) Fidelis XS (K990243) CuteraPearl (K070 138) Mosaic Lase… | 1999 |
| * | K070138 | Cutera ER:Yag Laser HandpieceSummary page 1…bium:YAG Surgical Laser System (K(933057) Fidelis XS (K990243) CuteraPearl (K070 138) Mosaic Laser System (K(070392) Erb… | 2007 |
| * | K070392 | Mosaic Laser SystemSummary page 3…S (K990243), Multilite Erbium:YAG Surgical Laser System (K933057), Cutera Pearl (K070138), Mosaic Laser System (K070392), Erbium Fractional Handpiece (K071768), Profile Multi-Platform System (K070388), CB… | 2007 |
| * | K071768 | Erbium Fractional HandpieceSummary page 1…earl (K070 138) Mosaic Laser System (K(070392) Erbium Fractional Handpiece (K071768) Profile Multi-Platform System (K(070388)… | 2007 |
| * | K070388 | Profile Multi-Platform SystemSummary page 3…(K070138), Mosaic Laser System (K070392), Erbium Fractional Handpiece (K071768), Profile Multi-Platform System (K070388), CB Erbium/2.94 (K970934), SmoothPeel (K unknown) Laser Peel, Fraxel S… | 2007 |
| * | — | SmoothPeel Laser Peel Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 10 months on median.
- 19 of the 374 ancestors have a recall of any class.
- 3 other devices also cite its predicate K970934.
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 DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows: Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece. Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae…
Read the full statement (100 words)
The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows:
Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece.
Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies.
The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073158 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073158: Sculpture 2.94 ER:Yag System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073158
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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