510(k) · Cleared
ClearedRD-1200H Normal Mode Ruby Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 9, 1996 after a 214-day review. The FDA summary names its predicate without a number. 1,548 later devices descend from it.
- Decided
- Jul 9, 1996
- Review
- 214 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1,548 later devices descend from it, 2 citing it directly.
- This deviceK955612 RD-1200H Normal Mode Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1996
- Descendant · cites it directly · 1,546 of its ownK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
- Descendant · 2 generations on · 1,535 of its ownK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
- Descendant · 3 generations on · 1,526 of its ownK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
- Descendant · 2 generations on · 1,509 of its ownK980517 Epilaser Normal Mode Ruby LaserPalomar Medical Products, Inc. · 1998
- Descendant · cites it directly · 1,497 of its ownK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
Showing 5 of 1,548 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,548 · See all- K963947Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997 · cites it directly1,546descendants
- K973324Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997 · 2 generations on1,535descendants
- K982940Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999 · 3 generations on1,526descendants
- K980517Epilaser Normal Mode Ruby LaserPalomar Medical Products, Inc. · 1998 · 2 generations on1,509descendants
- K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997 · cites it directly1,497descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955612 | RD-1200H Normal Mode Ruby Laser System | Spectrum Medical Technologies, Inc. | 1996 | — |
| +1 | K963947 | Epilaser Normal Mode Ruby Laser | Spectrum Medical Technologies, Inc. | 1997 | — |
| +2 | K973324 | Starlight Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1997 | — |
| +3 | K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | 1999 | — |
| +2 | K980517 | Epilaser Normal Mode Ruby Laser | Palomar Medical Products, Inc. | 1998 | — |
| +1 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 16 | 0 |
| 2003 | 28 | 0 |
| 2004 | 17 | 0 |
| 2005 | 29 | 0 |
| 2006 | 28 | 0 |
| 2007 | 32 | 0 |
| 2008 | 52 | 0 |
| 2009 | 39 | 0 |
| 2010 | 38 | 0 |
| 2011 | 39 | 0 |
| 2012 | 38 | 0 |
| 2013 | 56 | 0 |
| 2014 | 61 | 0 |
| 2015 | 54 | 0 |
| 2016 | 70 | 0 |
| 2017 | 71 | 0 |
| 2018 | 64 | 0 |
| 2019 | 55 | 0 |
| 2020 | 62 | 0 |
| 2021 | 79 | 0 |
| 2022 | 114 | 0 |
| 2023 | 109 | 0 |
| 2024 | 123 | 0 |
| 2025 | 162 | 0 |
| 2026 | 94 | 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? (2)
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 |
|---|---|---|---|
| * | — | pre-enactment normal mode ruby laser devices Named without a submission number | |
| * | — | post enactment devices Named without a submission number |
What descends from it? (1,548)
See all 1,5482 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?
- Of its descendants, K963947 (Spectrum Medical Technologies, Inc., 1997) has gone furthest, with 1,546 descendants of its own.
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 Spectrum Epilaser® has severa: indications for use based on the selective absorption of natural chromophores. particuiarly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black)
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/K955612 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955612: RD-1200H Normal Mode Ruby Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955612
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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