510(k) Report

510(k) · Cleared

Cleared

Model RD-1200 Ruby Laser System

K910422510(k) TraditionalCleared Apr 21, 1992447-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spectrum Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Apr 21, 1992 after a 447-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,503 later devices descend from it.

Decided
Apr 21, 1992
Review
447 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

1,503 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 3 descendants cleared2005: 26 descendants cleared2004: 15 descendants cleared1996: 1 descendant cleared1999: 1 descendant cleared1998: 1 descendant cleared2002: 11 descendants cleared2000: 1 descendant cleared2003: 23 descendants cleared2007: 32 descendants cleared2008: 49 descendants cleared2016: 70 descendants cleared2013: 55 descendants cleared2006: 27 descendants cleared2010: 38 descendants cleared2011: 37 descendants cleared2009: 37 descendants cleared2012: 35 descendants cleared2017: 69 descendants cleared2015: 52 descendants cleared2023: 107 descendants cleared2020: 62 descendants cleared2018: 63 descendants cleared2022: 114 descendants cleared2019: 55 descendants cleared2024: 123 descendants cleared2014: 61 descendants cleared2021: 79 descendants cleared2025: 162 descendants cleared2026: 94 descendants cleared1990200020102020
  1. This deviceK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
  2. Descendant · cites it directly · 1,499 of its ownK962109 SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser…Classy Lady by Mehl of Puerto Rico, Inc. · 1997
  3. Descendant · cites it directly · 1,498 of its ownK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
  4. Descendant · 2 generations on · 1,497 of its ownK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
  5. Descendant · 2 generations on · 1,496 of its ownK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
  6. Descendant · 3 generations on · 1,492 of its ownK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000

Showing 5 of 1,503 descendants. See all descendants

Descendants cleared per year

1996: 11997: 31998: 11999: 12000: 12002: 112003: 232004: 152005: 262006: 272007: 322008: 492009: 372010: 382011: 372012: 352013: 552014: 612015: 522016: 702017: 692018: 632019: 552020: 622021: 792022: 1142023: 1072024: 1232025: 1622026: 94
1996high 162 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 1,503 · See all
  • K962109SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair RemovalClassy Lady by Mehl of Puerto Rico, Inc. · 1997 · cites it directly1,499descendants
  • K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996 · cites it directly1,498descendants
  • K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997 · 2 generations on1,497descendants
  • K974536Photoderm HR SystemEsc Medical Systems, Ltd. · 1998 · 2 generations on1,496descendants
  • K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000 · 3 generations on1,492descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910422Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc.1992—
+1K962109SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair…Classy Lady by Mehl of Puerto Rico, Inc.1997—
+1K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.1996—
+2K962446Sharplan Ruby Laser SystemSharplan Lasers, Inc.1997—
+2K974536Photoderm HR SystemEsc Medical Systems, Ltd.1998—
+3K991935Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199730
199810
199910
200010
2002110
2003230
2004150
2005260
2006270
2007320
2008490
2009370
2010380
2011370
2012350
2013550
2014610
2015520
2016700
2017690
2018630
2019550
2020620
2021790
20221140
20231070
20241230
20251620
2026940
FIG. 1 — Lineage of K910422, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1,503)

See all 1,503

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K962109SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair RemovalClassy Lady by Mehl of Puerto Rico, Inc.19971,499
K961279Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc.19961,498
K040433SINONWavelight Laser Technologie AG20041
K050218Wavelight SinonWavelight Laser Technologie AG20050

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, K962109 (Classy Lady by Mehl of Puerto Rico, Inc., 1997) has gone furthest, with 1,499 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

More from Spectrum Medical Technologies, Inc.

3 FDA decisions under this applicant name. See the company

  • K963947Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
  • K955612RD-1200H Normal Mode Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1996

Recent decisions in GEX

The GEX category page

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  • K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd. · 2026
  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K910422 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910422: Model RD-1200 Ruby Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910422

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026